<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02250183</url>
  </required_header>
  <id_info>
    <org_study_id>13-021</org_study_id>
    <nct_id>NCT02250183</nct_id>
  </id_info>
  <brief_title>Medihoney and Santyl for Burn Injuries</brief_title>
  <acronym>MSBI</acronym>
  <official_title>A Comparison of Medihoney® Gel With Active Leptospermum Honey and Santyl® in the Treatment of Partial Thickness Burns</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Integra LifeSciences Corporation</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>West Virginia University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is designed to assess the efficacy of MEDIHONEY® Gel with Active leptospermum&#xD;
      honey dressing relative to SANTYL® ointment dressing on time to heal, bacterial growth in the&#xD;
      wound, patient satisfaction, and treatment costs in patients with partial thickness burns.&#xD;
      The study has four hypotheses:&#xD;
&#xD;
        1. It is hypothesized that MEDIHONEY® Gel with Active leptospermum honey will result in&#xD;
           significantly faster wound healing (i.e., fewer days) when compared to SANTYL®.&#xD;
&#xD;
        2. It is hypothesized that MEDIHONEY® Gel with Active leptospermum honey sites will yield&#xD;
           significantly fewer positive cultures for Pseudomonas aeruginosa and other bacteria when&#xD;
           compared to SANTYL® sites.&#xD;
&#xD;
        3. It is hypothesized that patients will provide significantly higher patient care&#xD;
           satisfaction ratings regarding their MEDIHONEY® Gel with Active leptospermum honey sites&#xD;
           when compared to ratings with regard to their SANTYL® sites.&#xD;
&#xD;
        4. It is hypothesized that treatment costs, across participants, will be significantly&#xD;
           lower for MEDIHONEY® Gel with Active leptospermum honey than for SANTYL®.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Researchers have examined the usefulness of honey as a treatment for a variety of wounds.&#xD;
      Molan outlines some of the benefits of honey in the treatment of wounds, such as its&#xD;
      effective antibacterial activity, debriding action, anti-inflammatory component, and&#xD;
      antioxidant activity. In addition, the acidity of honey may improve wound healing by&#xD;
      decreasing the pH of the wound and providing more oxygen, which ultimately helps to&#xD;
      regenerate tissue .&#xD;
&#xD;
      Many studies have demonstrated the effectiveness of honey's antibacterial properties. For&#xD;
      example, the antibacterial activity of honey has been shown to protect against&#xD;
      multi-resistant strains of bacteria including multi-resistant staphylococcus aureus (MRSA)&#xD;
      and Pseudomonas aeruginosa. In fact, research suggests that honey may be an effective&#xD;
      antibacterial agent for bacteria that were resistant to up to 13 different antibiotics.&#xD;
      Related specifically to burn injuries, results from another study indicated that honey may be&#xD;
      an effective antibacterial agent and treatment option for burn injuries infected with or at&#xD;
      risk for infection with Pseudomonas aeruginosa. Furthermore, unlike other antibiotics used in&#xD;
      clinical care, the possibility of developing honey-resistant wound pathogens is rare, even&#xD;
      when using high concentrations of honey, according to one study. Results from these studies&#xD;
      provide strong evidence for the usefulness of honey's antibacterial activity in the treatment&#xD;
      of wounds, including burn injuries.&#xD;
&#xD;
      In addition to its antibacterial properties, honey has been found to promote wound healing in&#xD;
      patients with burn injuries. For example, one study compared the effectiveness of a honey&#xD;
      dressing to silver sulfadiazene (SSD) on wound healing in 78 child and adult burn patients&#xD;
      with first and second degree burns. According to the results from this study, patients&#xD;
      treated with honey dressings had a significantly lower average duration of healing (in days)&#xD;
      compared to patients treated with SSD. In addition, approximately half of the wounds treated&#xD;
      with honey dressings became sterile within seven days while none of the wounds became sterile&#xD;
      during this span of time for the patients who were treated with SSD. The authors of this&#xD;
      study also reported that 30 of the 37 patients (81%) treated with honey achieved complete&#xD;
      recovery (i.e., complete healing two months post-burn injury without scarring or&#xD;
      contractures) compared to 15 out of 41 patients (37%) treated with SSD. Another study by&#xD;
      Baghel and colleagues using a similar sample found comparable results. In this second study,&#xD;
      patients who were treated with honey dressings were found to heal significantly faster, have&#xD;
      sterile wounds in less time, and have better overall recoveries (i.e., fewer hypertrophic&#xD;
      scars and contractures) when compared to those patients who were treated with SSD.&#xD;
&#xD;
      Another study compared honey and SSD on burn wound healing (i.e., improvement in burn wound&#xD;
      size and re-epithelialization) in patients with superficial partial thickness burns. Patients&#xD;
      included in this study had similar burns (e.g., second degree burns of similar depth) on&#xD;
      comparable burned surface areas (e.g., right hand and left hand). In addition, patients in&#xD;
      this study received both treatment options; that is, a patient's right hand was treated with&#xD;
      honey while his/her left hand was treated with SSD. Results from this study indicated that&#xD;
      the average healing time was significantly shorter for the body surfaces treated with honey.&#xD;
      Interestingly, the wounds treated with honey were found to heal approximately two days faster&#xD;
      than the wounds treated with SSD. Additionally, cultures of the wounds found that only six&#xD;
      patients tested positive for Pseudomonas aeruginosa in the sites that were treated with honey&#xD;
      compared to 27 patients in the sites treated with SSD. Two additional patients tested&#xD;
      positive for Escherichia coli infection in the wound sites that were treated with SSD. The&#xD;
      authors of this study concluded that honey was a more effective treatment for superficial&#xD;
      partial thickness burns than SSD.&#xD;
&#xD;
      Taken together, these studies provide preliminary evidence that honey may be an effective&#xD;
      treatment option for partial thickness burns, with benefits such as faster wound healing and&#xD;
      wound sterilization. In addition, MEDIHONEY® is cleared by the FDA to maintain a moist&#xD;
      environment conducive to wound healing. However, studies have yet to explore the&#xD;
      generalizability of these findings to samples of patients with burn injuries in the United&#xD;
      States, as all the previously cited studies were conducted outside of the United States. In&#xD;
      addition, studies thus far have examined the effectiveness of honey as a wound treatment and&#xD;
      have failed to evaluate patient care satisfaction with honey as a treatment option and the&#xD;
      treatment costs associated with the use of honey in clinical care. These two outcomes can&#xD;
      provide valuable insight into the appropriateness and feasibility of using honey in everyday&#xD;
      clinical care. Overall, information obtained from this study will yield knowledge on the&#xD;
      potential benefits of this product for burn wound treatment compared to standard care (i.e.,&#xD;
      SANTYL®).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Recruitment was too slow due to strict inclusion criteria.&#xD;
  </why_stopped>
  <start_date type="Actual">March 15, 2014</start_date>
  <completion_date type="Actual">August 18, 2016</completion_date>
  <primary_completion_date type="Actual">August 18, 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Wound Appearance</measure>
    <time_frame>Daily for 7 to 21 days, depending on time it takes burn injury to completely heal</time_frame>
    <description>Pictures of wounds and associated &quot;seepage test&quot; paper towels, without indication of date or arm of treatment, were rated by two independent physicians regarding healed or not yet healed. This information was then be used to calculate a &quot;time to heal&quot; variable (# of days) for each patient.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Presence vs. Absence of Bacteria in Burn Wound</measure>
    <time_frame>Day 7 of study</time_frame>
    <description>Wound swab culture results will be compared between treatment modalities via a McNemar test, with treatment modality (MEDIHONEY® GEL versus SANTYL® ointment) and outcome (Positive versus Negative wound culture results for presence of Pseudomonas aeruginosa and/or other bacteria) as the independent and dependent variables, respectively. Each participant has two wound cultures, one for MEDIHONEY® GEL and one for SANTYL® ointment.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Patient Satisfaction Questionnaire Score at End of Study Participation</measure>
    <time_frame>7 to 21 days after enrollment, depending on time it takes for burn injury to completely heal or to discontinue study participation</time_frame>
    <description>Patients rated their experience separately for MEDIHONEY &amp; SANTYL treatment. Responses were 6-point Likert type ratings across 6 items measuring pain, burn appearance, ease of use, and willingness to recommend that treatment to other patients. Potential score range was 6-36, with higher scores representing greater satisfaction.The mean difference in participant satisfaction for the MEDIHONEY® GEL and SANTYL® ointment treatments was assessed via a within-subject, two-tailed t-test.</description>
  </other_outcome>
  <other_outcome>
    <measure>Cost of Treatment (MEDIHONEY vs. SANTYL) Supplies</measure>
    <time_frame>At the end of treatment, which can last from 7 to 21 days after enrollment</time_frame>
    <description>The total treatment costs for MEDIHONEY® GEL and SANTYL® ointment will be summed across participants. The total number of SANTYL® tubes and MEDIHONEY® GEL patches used will be totaled for each participant, multiplied by cost, and then compared within subjects with a paired samples, t-test.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">21</enrollment>
  <condition>Burns</condition>
  <arm_group>
    <arm_group_label>Medihoney &amp; Santyl</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Each patient will receive both interventions simultaneously, but on non-contiguous parts of the body that each consist of partial thickness burn injuries of similar depth. For example, if a patient presents with bilateral second-degree burns to the lower extremities, one leg will be treated with MEDIHONEY® GEL with Active leptospermum honey dressing, while the other leg will be treated with SANTYL® ointment dressing. MEDIHONEY® is the target treatment for this study, while SANTYL® is standard care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MEDIHONEY® GEL WITH ACTIVE LEPTOSPERMUM HONEY</intervention_name>
    <description>MEDIHONEY® GEL WITH ACTIVE LEPTOSPERMUM HONEY dressing is manufactured by the company Derma Sciences, Inc. and is a moist dressing made of Active Leptospermum Honey (+15) in combination with natural gelling agents. The gelling agents act to maintain the physical integrity and viscosity of the dressing, even in the presence of body heat and fluids. As a percentage of the overall dressing, MEDIHONEY® GEL dressings contains 80% honey. The dressing has a low pH and can help to lower the overall pH of wounds. The dressing also possesses a high osmotic potential, which assists in debridement.</description>
    <arm_group_label>Medihoney &amp; Santyl</arm_group_label>
    <other_name>Medihoney</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Santyl</intervention_name>
    <description>SANTYL® Ointment is an FDA-approved sterile enzymatic debriding ointment which contains 250 collagenase units per gram of white petrolatum USP. The enzyme SANTYL® is derived from the fermentation by Clostridium histolyticum. It possesses the unique ability to digest collagen in necrotic tissue. SANTYL® Ointment is indicated for debriding chronic dermal ulcers and severely burned areas.</description>
    <arm_group_label>Medihoney &amp; Santyl</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  New patient presenting with a partial thickness burn injury in at least two&#xD;
             non-contiguous locations of the body.&#xD;
&#xD;
          -  Enrollment will occur within 72 hours of sustaining a burn injury.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cognitive or language barriers that preclude completion of study measures.&#xD;
&#xD;
          -  Have burn injuries exceeding 40% total body surface area (TBSA).&#xD;
&#xD;
          -  Have a diagnosis of immunodeficiency or kidney disease.&#xD;
&#xD;
          -  Are receiving treatment (e.g., chemotherapy, dialysis) that can create concerns with&#xD;
             immunodeficiency or affect healing.&#xD;
&#xD;
          -  Are pregnant.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ariel M Aballay, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Western Pennsylvania Hospital Burn Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Christina L Duncan, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>West Virginia University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Western Pennsylvania Hospital Burn Center</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Molan PC. The evidence and the rationale for the use of honey as a wound dressing. Wound Practice and Research, 19(4): 204-220, 2011.</citation>
  </reference>
  <reference>
    <citation>Blair SE, Cokcetin NN, Harry EJ, Carter DA. The unusual antibacterial activity of medical-grade Leptospermum honey: antibacterial spectrum, resistance and transcriptome analysis. Eur J Clin Microbiol Infect Dis. 2009 Oct;28(10):1199-208. doi: 10.1007/s10096-009-0763-z. Epub 2009 Jun 10.</citation>
    <PMID>19513768</PMID>
  </reference>
  <reference>
    <citation>George NM, Cutting KF. Antibacterial Honey (Medihoney): in-vitro Activity Against Clinical Isolates of MRSA, VRE, and Other Multiresistant Gram-negative Organisms Including Pseudomonas aeruginosa. Wounds. 2007 Sep;19(9):231-6.</citation>
    <PMID>25942744</PMID>
  </reference>
  <reference>
    <citation>Cooper RA, Halas E, Molan PC. The efficacy of honey in inhibiting strains of Pseudomonas aeruginosa from infected burns. J Burn Care Rehabil. 2002 Nov-Dec;23(6):366-70. doi: 10.1097/00004630-200211000-00002.</citation>
    <PMID>12432313</PMID>
  </reference>
  <reference>
    <citation>Cooper RA, Jenkins L, Henriques AF, Duggan RS, Burton NF. Absence of bacterial resistance to medical-grade manuka honey. Eur J Clin Microbiol Infect Dis. 2010 Oct;29(10):1237-41. doi: 10.1007/s10096-010-0992-1. Epub 2010 Jun 13.</citation>
    <PMID>20549529</PMID>
  </reference>
  <reference>
    <citation>Gupta SS, Singh O, Bhagel PS, Moses S, Shukla S, Mathur RK. Honey dressing versus silver sulfadiazene dressing for wound healing in burn patients: a retrospective study. J Cutan Aesthet Surg. 2011 Sep;4(3):183-7. doi: 10.4103/0974-2077.91249.</citation>
    <PMID>22279383</PMID>
  </reference>
  <reference>
    <citation>Baghel PS, Shukla S, Mathur RK, Randa R. A comparative study to evaluate the effect of honey dressing and silver sulfadiazene dressing on wound healing in burn patients. Indian J Plast Surg. 2009 Jul;42(2):176-81. doi: 10.4103/0970-0358.59276.</citation>
    <PMID>20368852</PMID>
  </reference>
  <reference>
    <citation>Malik KI, Malik MA, Aslam A. Honey compared with silver sulphadiazine in the treatment of superficial partial-thickness burns. Int Wound J. 2010 Oct;7(5):413-7. doi: 10.1111/j.1742-481X.2010.00717.x.</citation>
    <PMID>20649832</PMID>
  </reference>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>September 15, 2014</study_first_submitted>
  <study_first_submitted_qc>September 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2014</study_first_posted>
  <results_first_submitted>November 13, 2018</results_first_submitted>
  <results_first_submitted_qc>March 8, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">April 2, 2019</results_first_posted>
  <last_update_submitted>May 21, 2019</last_update_submitted>
  <last_update_submitted_qc>May 21, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 22, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>West Virginia University</investigator_affiliation>
    <investigator_full_name>Christina Duncan</investigator_full_name>
    <investigator_title>Professor of Psychology</investigator_title>
  </responsible_party>
  <keyword>Medihoney</keyword>
  <keyword>Santyl</keyword>
  <keyword>Burns</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Burns</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants were recruited largely from an outpatient burn care clinic in a hospital in the Northeastern U.S.. Some participants also were recruited during their hospitalization in the hospital's inpatient burn care center. The first participant was enrolled on 03/15/2014; the final participant was enrolled on 08/11/2016.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Medihoney &amp; Santyl</title>
          <description>Each patient received both interventions simultaneously, but on non-contiguous parts of the body (e.g., bilateral lower extremities), each with partial thickness burns of similar depth. One intervention was MEDIHONEY® GEL WITH ACTIVE LEPTOSPERMUM HONEY, a moist dressing made of Active Leptospermum Honey (+15) in combination with natural gelling agents. MEDIHONEY® GEL dressings contains 80% honey. The other intervention was SANTYL®, an FDA-approved sterile enzymatic debriding ointment which contains 250 collagenase units per gram of white petrolatum USP.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Total enrolled = 21. Only one pediatric participant was enrolled in this study. As an outlier, this participant was removed from all analyses. Another participant had missing data for all baseline measurement. Thus, total analyzed at baseline = 19.</population>
      <group_list>
        <group group_id="B1">
          <title>Medihoney &amp; Santyl</title>
          <description>Each patient received both interventions simultaneously, but on non-contiguous parts of the body (e.g., arm vs. leg), each with partial thickness burns of similar depth. One intervention was MEDIHONEY® GEL WITH ACTIVE LEPTOSPERMUM HONEY, a moist dressing made of Active Leptospermum Honey (+15) in combination with natural gelling agents. MEDIHONEY® GEL dressings contains 80% honey. The dressing has a low pH and can help to lower the overall pH of wounds. The dressing also possesses a high osmotic potential, which assists in debridement. The other intervention was SANTYL®, an FDA-approved sterile enzymatic debriding ointment which contains 250 collagenase units per gram of white petrolatum USP. SANTYL® Ointment is indicated for debriding chronic dermal ulcers and severely burned areas.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="19"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <population>Total enrolled = 21. Only one pediatric participant was enrolled in this study. As an outlier, this participant was removed from all analyses. Another participant had missing data for all baseline measurement. Thus, total analyzed at baseline = 19.</population>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="42.00" spread="14.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <population>Total enrolled = 21. Only one pediatric participant was enrolled in this study. As an outlier, this participant was removed from all analyses. Another participant had missing data for all baseline measurement. Thus, total analyzed at baseline = 19.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <population>Total enrolled = 21. Only one pediatric participant was enrolled in this study. As an outlier, this participant was removed from all analyses. Another participant had missing data for all baseline measurement. Thus, total analyzed at baseline = 19.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <population>Total enrolled = 21. Only one pediatric participant was enrolled in this study. As an outlier, this participant was removed from all analyses. Another participant had missing data for all baseline measurement. Thus, total analyzed at baseline = 19.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <population>Total enrolled = 21. Only one pediatric participant was enrolled in this study. As an outlier, this participant was removed from all analyses. Another participant had missing data for all baseline measurement. Thus, total analyzed at baseline = 19.</population>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Cause of Burn Injury</title>
          <description>Classification for cause of burn injury; measured by medical chart review</description>
          <population>Total enrolled = 21. Only one pediatric participant was enrolled in this study. As an outlier, this participant was removed from all analyses. Another participant had missing data for all baseline measurement. Thus, total analyzed at baseline = 19.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Thermal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Scald</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Contact</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Total Body Surface Area Burned</title>
          <description>Measured via medical chart review</description>
          <population>Total enrolled = 21. Only one pediatric participant was enrolled in this study. As an outlier, this participant was removed from all analyses. Another participant had missing data for all baseline measurement. Thus, total analyzed at baseline = 19.</population>
          <units>Total body surface area percentage</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4.75" spread="4.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Wound Appearance</title>
        <description>Pictures of wounds and associated &quot;seepage test&quot; paper towels, without indication of date or arm of treatment, were rated by two independent physicians regarding healed or not yet healed. This information was then be used to calculate a &quot;time to heal&quot; variable (# of days) for each patient.</description>
        <time_frame>Daily for 7 to 21 days, depending on time it takes burn injury to completely heal</time_frame>
        <population>Each participant received both arms of treatment to control for individual healing factors (thus, this is a single group study). Initial analyses yielded inconclusive agreement on healing time due to low quality of pictures (e.g., lighting, focus) and physician reported difficulty in using still photos in isolation to judge wound healing.</population>
        <group_list>
          <group group_id="O1">
            <title>Medihoney &amp; Santyl</title>
            <description>Each patient received both interventions (MEDIHONEY® GEL &amp; SANTYL® Ointment) simultaneously, but on non-contiguous parts of the body that each consisted of partial thickness burn injuries of similar depth. For example, if a patient presented with bilateral second-degree burns to the lower extremities, one leg was treated with MEDIHONEY® GEL with Active leptospermum honey dressing, while the other leg was treated with SANTYL® ointment dressing.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Wound Appearance</title>
          <description>Pictures of wounds and associated &quot;seepage test&quot; paper towels, without indication of date or arm of treatment, were rated by two independent physicians regarding healed or not yet healed. This information was then be used to calculate a &quot;time to heal&quot; variable (# of days) for each patient.</description>
          <population>Each participant received both arms of treatment to control for individual healing factors (thus, this is a single group study). Initial analyses yielded inconclusive agreement on healing time due to low quality of pictures (e.g., lighting, focus) and physician reported difficulty in using still photos in isolation to judge wound healing.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Presence vs. Absence of Bacteria in Burn Wound</title>
        <description>Wound swab culture results will be compared between treatment modalities via a McNemar test, with treatment modality (MEDIHONEY® GEL versus SANTYL® ointment) and outcome (Positive versus Negative wound culture results for presence of Pseudomonas aeruginosa and/or other bacteria) as the independent and dependent variables, respectively. Each participant has two wound cultures, one for MEDIHONEY® GEL and one for SANTYL® ointment.</description>
        <time_frame>Day 7 of study</time_frame>
        <population>Each participant received both arms of treatment to control for individual healing factors (thus, this is a single group study &amp; McNemar test is used). Seven participants had missing wound culture data for one or both treatment conditions.</population>
        <group_list>
          <group group_id="O1">
            <title>MEDIHONEY</title>
            <description>Each patient received both interventions (MEDIHONEY® GEL &amp; SANTYL® Ointment) simultaneously, but on non-contiguous parts of the body that each consisted of partial thickness burn injuries of similar depth. For example, if a patient presented with bilateral second-degree burns to the lower extremities, one leg was treated with MEDIHONEY® GEL with Active leptospermum honey dressing, while the other leg was treated with SANTYL® ointment dressing. This arm will be MEDIHONEY ® GEL.</description>
          </group>
          <group group_id="O2">
            <title>SANTYL</title>
            <description>Each patient received both interventions (MEDIHONEY® GEL &amp; SANTYL® Ointment) simultaneously, but on non-contiguous parts of the body that each consisted of partial thickness burn injuries of similar depth. For example, if a patient presented with bilateral second-degree burns to the lower extremities, one leg was treated with MEDIHONEY® GEL with Active leptospermum honey dressing, while the other leg was treated with SANTYL® ointment dressing. This arm will be SANTYL ® Ointment.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Presence vs. Absence of Bacteria in Burn Wound</title>
          <description>Wound swab culture results will be compared between treatment modalities via a McNemar test, with treatment modality (MEDIHONEY® GEL versus SANTYL® ointment) and outcome (Positive versus Negative wound culture results for presence of Pseudomonas aeruginosa and/or other bacteria) as the independent and dependent variables, respectively. Each participant has two wound cultures, one for MEDIHONEY® GEL and one for SANTYL® ointment.</description>
          <population>Each participant received both arms of treatment to control for individual healing factors (thus, this is a single group study &amp; McNemar test is used). Seven participants had missing wound culture data for one or both treatment conditions.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Negative Wound Culture</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Positive Wound Culture</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Each participant received both treatment modalities - MEDIHONEY® and SANTYL - and thus had two wound cultures performed, one for each treatment modality. This was a single group study; however, wound culture results were contrasted with each other across participants. Thus, independent variable was treatment modality, while dependent variable was the wound culture result (positive for presence of bacteria versus negative for absence of bacteria).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>1.00</p_value>
            <p_value_desc>A priori threshold for statistical significance was p&lt;0.05. Each case (participant) serves as its own control because they received both treatment modalities simultaneously.</p_value_desc>
            <method>McNemar</method>
            <method_desc>McNemar test was used because participants received both treatments, so this variable was non-independent in our single group sample.</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.000</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
            <estimate_desc>2-sided</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Patient Satisfaction Questionnaire Score at End of Study Participation</title>
        <description>Patients rated their experience separately for MEDIHONEY &amp; SANTYL treatment. Responses were 6-point Likert type ratings across 6 items measuring pain, burn appearance, ease of use, and willingness to recommend that treatment to other patients. Potential score range was 6-36, with higher scores representing greater satisfaction.The mean difference in participant satisfaction for the MEDIHONEY® GEL and SANTYL® ointment treatments was assessed via a within-subject, two-tailed t-test.</description>
        <time_frame>7 to 21 days after enrollment, depending on time it takes for burn injury to completely heal or to discontinue study participation</time_frame>
        <population>Each participant received both treatment arms (single group study). To reduce bias in results, participants not lost to follow-up were asked to complete this survey, regardless of whether they completed the study or discontinued participation due to withdrawal, need for treatment change, or adverse event. Six participants were missing this measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Medihoney &amp; Santyl</title>
            <description>Each patient received both interventions (MEDIHONEY® GEL &amp; SANTYL® Ointment) simultaneously, but on non-contiguous parts of the body that each consisted of partial thickness burn injuries of similar depth. For example, if a patient presented with bilateral second-degree burns to the lower extremities, one leg was treated with MEDIHONEY® GEL with Active leptospermum honey dressing, while the other leg was treated with SANTYL® ointment dressing.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Satisfaction Questionnaire Score at End of Study Participation</title>
          <description>Patients rated their experience separately for MEDIHONEY &amp; SANTYL treatment. Responses were 6-point Likert type ratings across 6 items measuring pain, burn appearance, ease of use, and willingness to recommend that treatment to other patients. Potential score range was 6-36, with higher scores representing greater satisfaction.The mean difference in participant satisfaction for the MEDIHONEY® GEL and SANTYL® ointment treatments was assessed via a within-subject, two-tailed t-test.</description>
          <population>Each participant received both treatment arms (single group study). To reduce bias in results, participants not lost to follow-up were asked to complete this survey, regardless of whether they completed the study or discontinued participation due to withdrawal, need for treatment change, or adverse event. Six participants were missing this measure.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>MEDIHONEY</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.86" spread="2.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SANTYL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.00" spread="3.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>A paired samples, 2-tailed, t-test was used to compare means within participants for ratings of MEDIHONEY and SANTYL satisfaction total scores. The null hypothesis was that the two mean scores would not differ significantly at p&lt;.05 level.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.003</p_value>
            <p_value_desc>The null hypothesis was that the two mean scores would not differ significantly at p&lt;.05 level.</p_value_desc>
            <method>t-test, 2 sided</method>
            <method_desc>df = 13</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>3.615</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>.790</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.149</ci_lower_limit>
            <ci_upper_limit>4.565</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Cost of Treatment (MEDIHONEY vs. SANTYL) Supplies</title>
        <description>The total treatment costs for MEDIHONEY® GEL and SANTYL® ointment will be summed across participants. The total number of SANTYL® tubes and MEDIHONEY® GEL patches used will be totaled for each participant, multiplied by cost, and then compared within subjects with a paired samples, t-test.</description>
        <time_frame>At the end of treatment, which can last from 7 to 21 days after enrollment</time_frame>
        <population>We did not analyze these data because we determined later that the values were confounded by multiple uncontrolled factors - i.e., size of the burn, unstandardized patient variation in amount of cream used (as treatment was performed at home). Normalizing values to burn size would not be sufficient to make valid comparison.</population>
        <group_list>
          <group group_id="O1">
            <title>Medihoney &amp; Santyl</title>
            <description>Each patient received both interventions (MEDIHONEY® GEL &amp; SANTYL® Ointment) simultaneously, but on non-contiguous parts of the body that each consisted of partial thickness burn injuries of similar depth. For example, if a patient presented with bilateral second-degree burns to the lower extremities, one leg was treated with MEDIHONEY® GEL with Active leptospermum honey dressing, while the other leg was treated with SANTYL® ointment dressing.</description>
          </group>
        </group_list>
        <measure>
          <title>Cost of Treatment (MEDIHONEY vs. SANTYL) Supplies</title>
          <description>The total treatment costs for MEDIHONEY® GEL and SANTYL® ointment will be summed across participants. The total number of SANTYL® tubes and MEDIHONEY® GEL patches used will be totaled for each participant, multiplied by cost, and then compared within subjects with a paired samples, t-test.</description>
          <population>We did not analyze these data because we determined later that the values were confounded by multiple uncontrolled factors - i.e., size of the burn, unstandardized patient variation in amount of cream used (as treatment was performed at home). Normalizing values to burn size would not be sufficient to make valid comparison.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event data were collected from the time of enrollment until the time of study completion, i.e., when wounds were healed, or study discontinuation due to participant withdrawing from research or experiencing an adverse event. Given expected healing time for these depth of burn wounds, adverse event data were gathered for up to 4 weeks after enrollment across all participants.</time_frame>
      <desc>Data were collected via physician examination during weekly follow-up clinic or hospital visits at days 7, 14, or 21 or during an unscheduled follow-up clinic visit (for outpatients) prompted by patient concerns (e.g., calling clinic to express concern about wound appearance). Adverse events were recorded in a log and reported to the IRB, per institutional standards.</desc>
      <group_list>
        <group group_id="E1">
          <title>Medihoney</title>
          <description>MEDIHONEY® was the target treatment for this arm. However, each patient received both interventions (MEDIHONEY® GEL &amp; SANTYL® Ointment) simultaneously, but on non-contiguous parts of the body that each consisted of partial thickness burn injuries of similar depth, to control for individual healing factors when comparing the treatments. For example, if a patient presented with bilateral second-degree burns to the lower extremities, one leg was treated with MEDIHONEY® GEL with Active leptospermum honey dressing, while the other leg was treated with SANTYL® ointment dressing.</description>
        </group>
        <group group_id="E2">
          <title>Santyl</title>
          <description>SANTYL® was the target treatment for this arm However, each patient received both interventions (MEDIHONEY® GEL &amp; SANTYL® Ointment) simultaneously, but on non-contiguous parts of the body that each consisted of partial thickness burn injuries of similar depth, to control for individual healing factors when comparing the treatments. For example, if a patient presented with bilateral second-degree burns to the lower extremities, one leg was treated with MEDIHONEY® GEL with Active leptospermum honey dressing, while the other leg was treated with SANTYL® ointment dressing.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Infection of the burn wound precipitating change in treatment to include prescribed antibiotics</sub_title>
                <description>Positive wound cultures do not necessarily indicate adverse event (AE) because of normal expected flora. Thus, AE was defined as only infections developing in the burn wound that precipiated a change in treatment to include prescribed antibiotics.</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Early termination resulting from strict inclusion criteria reduced sample size for analysis; Technical &amp; methodological problems in measurement (photos to gauge healing; treatment costs confounded by variation in gel use) led to uninterpretable data.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Ariel M. Aballay, MD</name_or_title>
      <organization>Allegheny Health Network-West Penn Hospital Burn Center</organization>
      <phone>412-578-1836</phone>
      <email>Ariel.Aballay@AHN.org</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02250183
org study id: 13-021
nct id: NCT02250183
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
This study is designed to assess the efficacy of MEDIHONEY® Gel with Active leptospermum
      honey dressing relative to SANTYL® ointment dressing on time to heal, bacterial growth in the
      wound, patient satisfaction, and treatment costs in patients with partial thickness burns.
      The study has four hypotheses:

        1. It is hypothesized that MEDIHONEY® Gel with Active leptospermum honey will result in
           significantly faster wound healing (i.e., fewer days) when compared to SANTYL®.

        2. It is hypothesized that MEDIHONEY® Gel with Active leptospermum honey sites will yield
           significantly fewer positive cultures for Pseudomonas aeruginosa and other bacteria when
           compared to SANTYL® sites.

        3. It is hypothesized that patients will provide significantly higher patient care
           satisfaction ratings regarding their MEDIHONEY® Gel with Active leptospermum honey sites
           when compared to ratings with regard to their SANTYL® sites.

        4. It is hypothesized that treatment costs, across participants, will be significantly
           lower for MEDIHONEY® Gel with Active leptospermum honey than for SANTYL®.
Researchers have examined the usefulness of honey as a treatment for a variety of wounds.
      Molan outlines some of the benefits of honey in the treatment of wounds, such as its
      effective antibacterial activity, debriding action, anti-inflammatory component, and
      antioxidant activity. In addition, the acidity of honey may improve wound healing by
      decreasing the pH of the wound and providing more oxygen, which ultimately helps to
      regenerate tissue .

      Many studies have demonstrated the effectiveness of honey's antibacterial properties. For
      example, the antibacterial activity of honey has been shown to protect against
      multi-resistant strains of bacteria including multi-resistant staphylococcus aureus (MRSA)
      and Pseudomonas aeruginosa. In fact, research suggests that honey may be an effective
      antibacterial agent for bacteria that were resistant to up to 13 different antibiotics.
      Related specifically to burn injuries, results from another study indicated that honey may be
      an effective antibacterial agent and treatment option for burn injuries infected with or at
      risk for infection with Pseudomonas aeruginosa. Furthermore, unlike other antibiotics used in
      clinical care, the possibility of developing honey-resistant wound pathogens is rare, even
      when using high concentrations of honey, according to one study. Results from these studies
      provide strong evidence for the usefulness of honey's antibacterial activity in the treatment
      of wounds, including burn injuries.

      In addition to its antibacterial properties, honey has been found to promote wound healing in
      patients with burn injuries. For example, one study compared the effectiveness of a honey
      dressing to silver sulfadiazene (SSD) on wound healing in 78 child and adult burn patients
      with first and second degree burns. According to the results from this study, patients
      treated with honey dressings had a significantly lower average duration of healing (in days)
      compared to patients treated with SSD. In addition, approximately half of the wounds treated
      with honey dressings became sterile within seven days while none of the wounds became sterile
      during this span of time for the patients who were treated with SSD. The authors of this
      study also reported that 30 of the 37 patients (81%) treated with honey achieved complete
      recovery (i.e., complete healing two months post-burn injury without scarring or
      contractures) compared to 15 out of 41 patients (37%) treated with SSD. Another study by
      Baghel and colleagues using a similar sample found comparable results. In this second study,
      patients who were treated with honey dressings were found to heal significantly faster, have
      sterile wounds in less time, and have better overall recoveries (i.e., fewer hypertrophic
      scars and contractures) when compared to those patients who were treated with SSD.

      Another study compared honey and SSD on burn wound healing (i.e., improvement in burn wound
      size and re-epithelialization) in patients with superficial partial thickness burns. Patients
      included in this study had similar burns (e.g., second degree burns of similar depth) on
      comparable burned surface areas (e.g., right hand and left hand). In addition, patients in
      this study received both treatment options; that is, a patient's right hand was treated with
      honey while his/her left hand was treated with SSD. Results from this study indicated that
      the average healing time was significantly shorter for the body surfaces treated with honey.
      Interestingly, the wounds treated with honey were found to heal approximately two days faster
      than the wounds treated with SSD. Additionally, cultures of the wounds found that only six
      patients tested positive for Pseudomonas aeruginosa in the sites that were treated with honey
      compared to 27 patients in the sites treated with SSD. Two additional patients tested
      positive for Escherichia coli infection in the wound sites that were treated with SSD. The
      authors of this study concluded that honey was a more effective treatment for superficial
      partial thickness burns than SSD.

      Taken together, these studies provide preliminary evidence that honey may be an effective
      treatment option for partial thickness burns, with benefits such as faster wound healing and
      wound sterilization. In addition, MEDIHONEY® is cleared by the FDA to maintain a moist
      environment conducive to wound healing. However, studies have yet to explore the
      generalizability of these findings to samples of patients with burn injuries in the United
      States, as all the previously cited studies were conducted outside of the United States. In
      addition, studies thus far have examined the effectiveness of honey as a wound treatment and
      have failed to evaluate patient care satisfaction with honey as a treatment option and the
      treatment costs associated with the use of honey in clinical care. These two outcomes can
      provide valuable insight into the appropriateness and feasibility of using honey in everyday
      clinical care. Overall, information obtained from this study will yield knowledge on the
      potential benefits of this product for burn wound treatment compared to standard care (i.e.,
      SANTYL®).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in Wound Appearance
time frame: Daily for 7 to 21 days, depending on time it takes burn injury to completely heal
description: Pictures of wounds and associated "seepage test" paper towels, without indication of date or arm of treatment, were rated by two independent physicians regarding healed or not yet healed. This information was then be used to calculate a "time to heal" variable (# of days) for each patient.
measure: Number of Participants With Presence vs. Absence of Bacteria in Burn Wound
time frame: Day 7 of study
description: Wound swab culture results will be compared between treatment modalities via a McNemar test, with treatment modality (MEDIHONEY® GEL versus SANTYL® ointment) and outcome (Positive versus Negative wound culture results for presence of Pseudomonas aeruginosa and/or other bacteria) as the independent and dependent variables, respectively. Each participant has two wound cultures, one for MEDIHONEY® GEL and one for SANTYL® ointment.
measure: Patient Satisfaction Questionnaire Score at End of Study Participation
time frame: 7 to 21 days after enrollment, depending on time it takes for burn injury to completely heal or to discontinue study participation
description: Patients rated their experience separately for MEDIHONEY & SANTYL treatment. Responses were 6-point Likert type ratings across 6 items measuring pain, burn appearance, ease of use, and willingness to recommend that treatment to other patients. Potential score range was 6-36, with higher scores representing greater satisfaction.The mean difference in participant satisfaction for the MEDIHONEY® GEL and SANTYL® ointment treatments was assessed via a within-subject, two-tailed t-test.
measure: Cost of Treatment (MEDIHONEY vs. SANTYL) Supplies
time frame: At the end of treatment, which can last from 7 to 21 days after enrollment
description: The total treatment costs for MEDIHONEY® GEL and SANTYL® ointment will be summed across participants. The total number of SANTYL® tubes and MEDIHONEY® GEL patches used will be totaled for each participant, multiplied by cost, and then compared within subjects with a paired samples, t-test.
arm group label: Medihoney & Santyl
arm group type: Other
description: Each patient will receive both interventions simultaneously, but on non-contiguous parts of the body that each consist of partial thickness burn injuries of similar depth. For example, if a patient presents with bilateral second-degree burns to the lower extremities, one leg will be treated with MEDIHONEY® GEL with Active leptospermum honey dressing, while the other leg will be treated with SANTYL® ointment dressing. MEDIHONEY® is the target treatment for this study, while SANTYL® is standard care.
intervention type: Device
intervention name: MEDIHONEY® GEL WITH ACTIVE LEPTOSPERMUM HONEY
description: MEDIHONEY® GEL WITH ACTIVE LEPTOSPERMUM HONEY dressing is manufactured by the company Derma Sciences, Inc. and is a moist dressing made of Active Leptospermum Honey (+15) in combination with natural gelling agents. The gelling agents act to maintain the physical integrity and viscosity of the dressing, even in the presence of body heat and fluids. As a percentage of the overall dressing, MEDIHONEY® GEL dressings contains 80% honey. The dressing has a low pH and can help to lower the overall pH of wounds. The dressing also possesses a high osmotic potential, which assists in debridement.
arm group label: Medihoney & Santyl
other name: Medihoney
intervention type: Device
intervention name: Santyl
description: SANTYL® Ointment is an FDA-approved sterile enzymatic debriding ointment which contains 250 collagenase units per gram of white petrolatum USP. The enzyme SANTYL® is derived from the fermentation by Clostridium histolyticum. It possesses the unique ability to digest collagen in necrotic tissue. SANTYL® Ointment is indicated for debriding chronic dermal ulcers and severely burned areas.
arm group label: Medihoney & Santyl
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Ariel M Aballay, MD
role: Principal Investigator
affiliation: Western Pennsylvania Hospital Burn Center
last name: Christina L Duncan, PhD
role: Principal Investigator
affiliation: West Virginia University
facility: 
country: United States
citation: Molan PC. The evidence and the rationale for the use of honey as a wound dressing. Wound Practice and Research, 19(4): 204-220, 2011.
citation: Blair SE, Cokcetin NN, Harry EJ, Carter DA. The unusual antibacterial activity of medical-grade Leptospermum honey: antibacterial spectrum, resistance and transcriptome analysis. Eur J Clin Microbiol Infect Dis. 2009 Oct;28(10):1199-208. doi: 10.1007/s10096-009-0763-z. Epub 2009 Jun 10.
PMID: 19513768
citation: George NM, Cutting KF. Antibacterial Honey (Medihoney): in-vitro Activity Against Clinical Isolates of MRSA, VRE, and Other Multiresistant Gram-negative Organisms Including Pseudomonas aeruginosa. Wounds. 2007 Sep;19(9):231-6.
PMID: 25942744
citation: Cooper RA, Halas E, Molan PC. The efficacy of honey in inhibiting strains of Pseudomonas aeruginosa from infected burns. J Burn Care Rehabil. 2002 Nov-Dec;23(6):366-70. doi: 10.1097/00004630-200211000-00002.
PMID: 12432313
citation: Cooper RA, Jenkins L, Henriques AF, Duggan RS, Burton NF. Absence of bacterial resistance to medical-grade manuka honey. Eur J Clin Microbiol Infect Dis. 2010 Oct;29(10):1237-41. doi: 10.1007/s10096-010-0992-1. Epub 2010 Jun 13.
PMID: 20549529
citation: Gupta SS, Singh O, Bhagel PS, Moses S, Shukla S, Mathur RK. Honey dressing versus silver sulfadiazene dressing for wound healing in burn patients: a retrospective study. J Cutan Aesthet Surg. 2011 Sep;4(3):183-7. doi: 10.4103/0974-2077.91249.
PMID: 22279383
citation: Baghel PS, Shukla S, Mathur RK, Randa R. A comparative study to evaluate the effect of honey dressing and silver sulfadiazene dressing on wound healing in burn patients. Indian J Plast Surg. 2009 Jul;42(2):176-81. doi: 10.4103/0970-0358.59276.
PMID: 20368852
citation: Malik KI, Malik MA, Aslam A. Honey compared with silver sulphadiazine in the treatment of superficial partial-thickness burns. Int Wound J. 2010 Oct;7(5):413-7. doi: 10.1111/j.1742-481X.2010.00717.x.
PMID: 20649832
responsible party type: Principal Investigator
investigator affiliation: West Virginia University
investigator full name: Christina Duncan
investigator title: Professor of Psychology
mesh term: Burns
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Early termination resulting from strict inclusion criteria reduced sample size for analysis; Technical & methodological problems in measurement (photos to gauge healing; treatment costs confounded by variation in gel use) led to uninterpretable data.
point of contact: 