<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/NCT02259491</url>
  </required_header>
  <id_info>
    <org_study_id>GCO 13-1507</org_study_id>
    <nct_id>NCT02259491</nct_id>
  </id_info>
  <brief_title>Manuka Honey for Wound Care</brief_title>
  <official_title>Honey Dressings for Local Wound Care of Split Thickness Skin Graft and Free Tissue Transfer Donor Sites: A Prospective, Randomized, Controlled Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Icahn School of Medicine at Mount Sinai</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Icahn School of Medicine at Mount Sinai</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Since antiquity, honey has been recognized for its healing properties. Literature about the&#xD;
      use of medicinal honey for wound care dates back centuries with recent data suggesting its&#xD;
      use in patients suffering from burns or pressure ulcers. Research has shown Manuka honey&#xD;
      (Leptospermum scoparium) to have significant immune benefits and the ability to influence all&#xD;
      phases of wound healing: inflammation, proliferation and remodeling. In addition, numerous&#xD;
      clinical studies have identified positive benefits for wound healing. However, there is a&#xD;
      lack of prospective, randomized controlled data on the use of honey as a medicinal agent in&#xD;
      local wound care and scar healing.&#xD;
&#xD;
      In order to better understand Manuka Honey's ability to aid in healing, the investigators are&#xD;
      conducting a randomized, controlled, single-blinded study of patients undergoing&#xD;
      reconstructive surgery. This project uses split thickness skin graft and free tissue transfer&#xD;
      donor sites as standard wound models to compare the effects of Manuka Honey versus standard&#xD;
      wound care therapies. Through the use of standard wound model and objective measurement&#xD;
      tools, the investigators hope to better elucidate any benefits of this novel wound care&#xD;
      'technology.'&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Free tissue transfer (FTT) and split-thickness skin grafting (STSG) are important aspects of&#xD;
      head and neck reconstruction. The radial forearm skin flap and fibula osteocutaneous flap are&#xD;
      commonly used in head and neck reconstruction. After harvest, closure of these donor sites&#xD;
      often requires split thickness skin grafting. The grafting is usually done from the thigh.&#xD;
      The grafted free flap donor site along with the STSG donor site is often the source of&#xD;
      significant post-operative pain and complications including delayed wound healing, graft loss&#xD;
      and infection. There is no consensus in the literature on the best care for these donor sites&#xD;
      with surgeons employing a wide variety of surgical dressings for local wound care. There is&#xD;
      literature dating back centuries on the use of medicinal honey for wound care, with recent&#xD;
      data suggesting its use in patients suffering from burns or pressure ulcers. However, there&#xD;
      is a lack of prospective, randomized controlled data on the use of honey as a medicinal agent&#xD;
      in local wound care.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <start_date>December 2013</start_date>
  <completion_date type="Actual">January 12, 2017</completion_date>
  <primary_completion_date type="Actual">January 12, 2017</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Scar Scale</measure>
    <time_frame>up to 7 days</time_frame>
    <description>Physician assessment of scar by Modified Vancouver Scar Scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain scores</measure>
    <time_frame>up to 7 days</time_frame>
    <description>Assessed by standardized and validated post-operative pain scores</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Wound Healing</condition>
  <arm_group>
    <arm_group_label>Manuka Honey Dressing</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patient receive manuka honey dressings on skin graft and free flap donor sites</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Tegaderm and xeroform gauze</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patient receive standard wound care on skin graft and free flap donor sites which includes a tegaderm over the STSG site and xeroform gauze covered with dry gauze, kerlex and a cast for the STSG recipient site</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Manuka Honey Dressing</intervention_name>
    <description>After surgical resection and reconstruction the skin graft donor site (thigh) and the free flap donor site will be dressed with Medihoney surgical dressings. More specifically, a dressing of appropriate size will be applied to the anterior thigh and covered with tegaderm. For the STSG recipient site a Medihoney dressing will cover the skin graft, followed by dry gauze, kerlex and a cast.</description>
    <arm_group_label>Manuka Honey Dressing</arm_group_label>
    <other_name>Medihoney</other_name>
    <other_name>Calcium algninate dressings</other_name>
    <other_name>Dermasciences</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients over the age of 18 undergoing reconstructive surgery with FTT and/or STSG&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  All patients under the age of 18&#xD;
&#xD;
          -  Any patients with documented honey allergy&#xD;
&#xD;
          -  Patients with documented collagen vascular diseases&#xD;
&#xD;
          -  Patients with documented coagulopathy&#xD;
&#xD;
          -  Patients with history of prior skin grafting&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joshua Rosenberg, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Icahn School of Medicine at Mount Sinai</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Icahn School of Medicine at Mount Sinai</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>October 1, 2014</study_first_submitted>
  <study_first_submitted_qc>October 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 8, 2014</study_first_posted>
  <last_update_submitted>January 7, 2020</last_update_submitted>
  <last_update_submitted_qc>January 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Wound Healing</keyword>
  <keyword>Honey</keyword>
  <keyword>Skin Grafts</keyword>
  <keyword>Free tissue transfer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Calcium</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT02259491
org study id: GCO 13-1507
nct id: NCT02259491
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Since antiquity, honey has been recognized for its healing properties. Literature about the
      use of medicinal honey for wound care dates back centuries with recent data suggesting its
      use in patients suffering from burns or pressure ulcers. Research has shown Manuka honey
      (Leptospermum scoparium) to have significant immune benefits and the ability to influence all
      phases of wound healing: inflammation, proliferation and remodeling. In addition, numerous
      clinical studies have identified positive benefits for wound healing. However, there is a
      lack of prospective, randomized controlled data on the use of honey as a medicinal agent in
      local wound care and scar healing.

      In order to better understand Manuka Honey's ability to aid in healing, the investigators are
      conducting a randomized, controlled, single-blinded study of patients undergoing
      reconstructive surgery. This project uses split thickness skin graft and free tissue transfer
      donor sites as standard wound models to compare the effects of Manuka Honey versus standard
      wound care therapies. Through the use of standard wound model and objective measurement
      tools, the investigators hope to better elucidate any benefits of this novel wound care
      'technology.'
Free tissue transfer (FTT) and split-thickness skin grafting (STSG) are important aspects of
      head and neck reconstruction. The radial forearm skin flap and fibula osteocutaneous flap are
      commonly used in head and neck reconstruction. After harvest, closure of these donor sites
      often requires split thickness skin grafting. The grafting is usually done from the thigh.
      The grafted free flap donor site along with the STSG donor site is often the source of
      significant post-operative pain and complications including delayed wound healing, graft loss
      and infection. There is no consensus in the literature on the best care for these donor sites
      with surgeons employing a wide variety of surgical dressings for local wound care. There is
      literature dating back centuries on the use of medicinal honey for wound care, with recent
      data suggesting its use in patients suffering from burns or pressure ulcers. However, there
      is a lack of prospective, randomized controlled data on the use of honey as a medicinal agent
      in local wound care.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Scar Scale
time frame: up to 7 days
description: Physician assessment of scar by Modified Vancouver Scar Scale
measure: Pain scores
time frame: up to 7 days
description: Assessed by standardized and validated post-operative pain scores
arm group label: Manuka Honey Dressing
arm group type: Experimental
description: Patient receive manuka honey dressings on skin graft and free flap donor sites
arm group label: Tegaderm and xeroform gauze
arm group type: No Intervention
description: Patient receive standard wound care on skin graft and free flap donor sites which includes a tegaderm over the STSG site and xeroform gauze covered with dry gauze, kerlex and a cast for the STSG recipient site
intervention type: Other
intervention name: Manuka Honey Dressing
description: After surgical resection and reconstruction the skin graft donor site (thigh) and the free flap donor site will be dressed with Medihoney surgical dressings. More specifically, a dressing of appropriate size will be applied to the anterior thigh and covered with tegaderm. For the STSG recipient site a Medihoney dressing will cover the skin graft, followed by dry gauze, kerlex and a cast.
arm group label: Manuka Honey Dressing
other name: Medihoney
other name: Calcium algninate dressings
other name: Dermasciences
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Joshua Rosenberg, MD
role: Principal Investigator
affiliation: Icahn School of Medicine at Mount Sinai
facility: 
country: United States
responsible party type: Sponsor
mesh term: Wounds and Injuries
mesh term: Calcium