<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/NCT02994589</url>
  </required_header>
  <id_info>
    <org_study_id>5150267</org_study_id>
    <nct_id>NCT02994589</nct_id>
  </id_info>
  <brief_title>A Comparison of OASIS Wound Matrix With Approved Dressings for Skin Graft Donor Sites</brief_title>
  <acronym>OASIS</acronym>
  <official_title>A Comparison of OASIS Wound Matrix With Approved Dressings for Split Thickness Skin Graft Donor Sites</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Loma Linda University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Loma Linda University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators objective is to compare OASIS wound matrix with other commonly used&#xD;
      dressings available for the donor site in split thickness skin grafting in order to determine&#xD;
      which dressing provides the best outcome based on pain level, time to healing and aesthetic&#xD;
      outcome.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Investigators seek to compare Oasis wound matrix with Tegaderm and Xeroform in order to&#xD;
      determine whether advantages exist in one or more of the dressing types that are approved and&#xD;
      currently used for split-thickness skin graft donor site dressings.&#xD;
&#xD;
      Patients will be randomly assigned to one of the three treatment groups and followed up&#xD;
      post-operatively and treated as per current standard of care.&#xD;
&#xD;
      Data to be collected and analyzed includes: patient age, co-morbid illnesses, medication,&#xD;
      skin-graft donor location, skin-graft donor area, STSG thickness, infection rate,&#xD;
      complications involving the donor site, post-operative pain score every morning until&#xD;
      hospital discharge, healing rate, photographs of the donor site immediately post-operatively&#xD;
      and then at routine follow-up appointments.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Study was never started&#xD;
  </why_stopped>
  <start_date>October 2016</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">December 2016</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>Factorial Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time to Heal</measure>
    <time_frame>7-21 days</time_frame>
    <description>Patient will be followed up during routine post-operative appointments at the clinic weekly to check the healing process of the donor site wound.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Aesthetic Outcome</measure>
    <time_frame>1-12 weeks</time_frame>
    <description>During routine followup visits to the clinic, the donor site aesthetic outcome will be observed and recorded clinically and digitally (photographs). The Vancouver Scar Scale will be used.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain intensity measure</measure>
    <time_frame>7 days</time_frame>
    <description>Self reported pain intensity in the morning and evening with activity over the past 7 days. Each item is scored on a scale of 0-10 (0= no pain, 10= highest intensity of pain)</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Skin Graft Complications</condition>
  <arm_group>
    <arm_group_label>OASIS® wound matrix</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>OASIS wound matrix is a biologic extracellular matrix derived from porcine small intestine submucosa. Some components of OASIS wound matrix are similar to human dermis including types of collagens, elastin, glycoproteins and proteoglycans. In addition, OASIS wound matrix retains some growth factors that have been suggested to aid in the wound healing process. It is a FDA approved wound dressing indicated for use in a variety of ulcers, abrasions and surgical wounds.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Tegaderm™(Absorbant, 3M)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Transparent dressing allows for wound monitoring without changing the dressing Clear design takes the guesswork out of application over the wound Novel acrylic polymer pad technology designed to handle low to moderate wound drainage. No dressing breakdown in the wound. Low friction surface minimizes potential for friction and shear. Allows for gentle removal from skin. Barrier to external contaminants, body fluids, bacteria and viruses.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Xeroform™</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Xeroform™ Occlusive Petrolatum Gauze. 3% Bismuth Tribromophenate in a special petrolatum blend on fine mesh gauze. Non-adherent. Clings and conforms to all body contours.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Tegaderm™(Absorbant, 3M)</intervention_name>
    <description>3M™ Tegaderm™ Dressing helps provide the natural moisture balance conducive to wound healing.</description>
    <arm_group_label>Tegaderm™(Absorbant, 3M)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>OASIS® wound matrix</intervention_name>
    <description>OASIS® Matrix is indicated for the management of wounds including: partial- and full-thickness wounds, pressure ulcers, venous ulcers, chronic vascular ulcers, diabetic ulcers, trauma wounds (abrasions, lacerations, second-degree burns, skin tears), draining wounds, surgical wounds (donor sites/grafts, post-Mohs' surgery, post-laser surgery, podiatric, wound dehiscence).</description>
    <arm_group_label>OASIS® wound matrix</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Xeroform™</intervention_name>
    <description>Xeroform™ consists of a fine-mesh gauze impregnated with bismuth tribromophenate.</description>
    <arm_group_label>Xeroform™</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients scheduled to undergo split thickness skin grafting&#xD;
&#xD;
          -  patients able to consent without a proxy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  confounding medical conditions&#xD;
&#xD;
          -  previous skin grafting from site&#xD;
&#xD;
          -  prior use of biological skin substitute on site&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Subhas Gupta, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Loma Linda University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hahns Kim, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Loma Linda University</affiliation>
  </overall_official>
  <results_reference>
    <citation>Mostow EN, Haraway GD, Dalsing M, Hodde JP, King D; OASIS Venus Ulcer Study Group. Effectiveness of an extracellular matrix graft (OASIS Wound Matrix) in the treatment of chronic leg ulcers: a randomized clinical trial. J Vasc Surg. 2005 May;41(5):837-43. doi: 10.1016/j.jvs.2005.01.042.</citation>
    <PMID>15886669</PMID>
  </results_reference>
  <results_reference>
    <citation>Hankin CS, Knispel J, Lopes M, Bronstone A, Maus E. Clinical and cost efficacy of advanced wound care matrices for venous ulcers. J Manag Care Pharm. 2012 Jun;18(5):375-84. doi: 10.18553/jmcp.2012.18.5.375.</citation>
    <PMID>22663170</PMID>
  </results_reference>
  <results_reference>
    <citation>Eskes AM, Brolmann FE, Gerbens LA, Ubbink DT, Vermeulen H; REMBRANDT study group. Which dressing do donor site wounds need?: study protocol for a randomized controlled trial. Trials. 2011 Oct 17;12:229. doi: 10.1186/1745-6215-12-229.</citation>
    <PMID>21999705</PMID>
  </results_reference>
  <results_reference>
    <citation>Fernandes de Carvalho V, Paggiaro AO, Isaac C, Gringlas J, Ferreira MC. Clinical trial comparing 3 different wound dressings for the management of partial-thickness skin graft donor sites. J Wound Ostomy Continence Nurs. 2011 Nov-Dec;38(6):643-7. doi: 10.1097/WON.0b013e3182349d2f.</citation>
    <PMID>22011820</PMID>
  </results_reference>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>August 31, 2015</study_first_submitted>
  <study_first_submitted_qc>December 13, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 16, 2016</study_first_posted>
  <last_update_submitted>December 13, 2016</last_update_submitted>
  <last_update_submitted_qc>December 13, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 16, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02994589
org study id: 5150267
nct id: NCT02994589
lead sponsor: 
has dmc: No
The investigators objective is to compare OASIS wound matrix with other commonly used
      dressings available for the donor site in split thickness skin grafting in order to determine
      which dressing provides the best outcome based on pain level, time to healing and aesthetic
      outcome.
Investigators seek to compare Oasis wound matrix with Tegaderm and Xeroform in order to
      determine whether advantages exist in one or more of the dressing types that are approved and
      currently used for split-thickness skin graft donor site dressings.

      Patients will be randomly assigned to one of the three treatment groups and followed up
      post-operatively and treated as per current standard of care.

      Data to be collected and analyzed includes: patient age, co-morbid illnesses, medication,
      skin-graft donor location, skin-graft donor area, STSG thickness, infection rate,
      complications involving the donor site, post-operative pain score every morning until
      hospital discharge, healing rate, photographs of the donor site immediately post-operatively
      and then at routine follow-up appointments.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Time to Heal
time frame: 7-21 days
description: Patient will be followed up during routine post-operative appointments at the clinic weekly to check the healing process of the donor site wound.
measure: Aesthetic Outcome
time frame: 1-12 weeks
description: During routine followup visits to the clinic, the donor site aesthetic outcome will be observed and recorded clinically and digitally (photographs). The Vancouver Scar Scale will be used.
measure: Pain intensity measure
time frame: 7 days
description: Self reported pain intensity in the morning and evening with activity over the past 7 days. Each item is scored on a scale of 0-10 (0= no pain, 10= highest intensity of pain)
arm group label: OASIS® wound matrix
arm group type: Experimental
description: OASIS wound matrix is a biologic extracellular matrix derived from porcine small intestine submucosa. Some components of OASIS wound matrix are similar to human dermis including types of collagens, elastin, glycoproteins and proteoglycans. In addition, OASIS wound matrix retains some growth factors that have been suggested to aid in the wound healing process. It is a FDA approved wound dressing indicated for use in a variety of ulcers, abrasions and surgical wounds.
arm group label: Tegaderm™(Absorbant, 3M)
arm group type: Active Comparator
description: Transparent dressing allows for wound monitoring without changing the dressing Clear design takes the guesswork out of application over the wound Novel acrylic polymer pad technology designed to handle low to moderate wound drainage. No dressing breakdown in the wound. Low friction surface minimizes potential for friction and shear. Allows for gentle removal from skin. Barrier to external contaminants, body fluids, bacteria and viruses.
arm group label: Xeroform™
arm group type: Active Comparator
description: Xeroform™ Occlusive Petrolatum Gauze. 3% Bismuth Tribromophenate in a special petrolatum blend on fine mesh gauze. Non-adherent. Clings and conforms to all body contours.
intervention type: Other
intervention name: Tegaderm™(Absorbant, 3M)
description: 3M™ Tegaderm™ Dressing helps provide the natural moisture balance conducive to wound healing.
arm group label: Tegaderm™(Absorbant, 3M)
intervention type: Device
intervention name: OASIS® wound matrix
description: OASIS® Matrix is indicated for the management of wounds including: partial- and full-thickness wounds, pressure ulcers, venous ulcers, chronic vascular ulcers, diabetic ulcers, trauma wounds (abrasions, lacerations, second-degree burns, skin tears), draining wounds, surgical wounds (donor sites/grafts, post-Mohs' surgery, post-laser surgery, podiatric, wound dehiscence).
arm group label: OASIS® wound matrix
intervention type: Other
intervention name: Xeroform™
description: Xeroform™ consists of a fine-mesh gauze impregnated with bismuth tribromophenate.
arm group label: Xeroform™
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Subhas Gupta, MD, PhD
role: Study Chair
affiliation: Loma Linda University
last name: Hahns Kim, MD
role: Principal Investigator
affiliation: Loma Linda University
citation: Mostow EN, Haraway GD, Dalsing M, Hodde JP, King D; OASIS Venus Ulcer Study Group. Effectiveness of an extracellular matrix graft (OASIS Wound Matrix) in the treatment of chronic leg ulcers: a randomized clinical trial. J Vasc Surg. 2005 May;41(5):837-43. doi: 10.1016/j.jvs.2005.01.042.
PMID: 15886669
citation: Hankin CS, Knispel J, Lopes M, Bronstone A, Maus E. Clinical and cost efficacy of advanced wound care matrices for venous ulcers. J Manag Care Pharm. 2012 Jun;18(5):375-84. doi: 10.18553/jmcp.2012.18.5.375.
PMID: 22663170
citation: Eskes AM, Brolmann FE, Gerbens LA, Ubbink DT, Vermeulen H; REMBRANDT study group. Which dressing do donor site wounds need?: study protocol for a randomized controlled trial. Trials. 2011 Oct 17;12:229. doi: 10.1186/1745-6215-12-229.
PMID: 21999705
citation: Fernandes de Carvalho V, Paggiaro AO, Isaac C, Gringlas J, Ferreira MC. Clinical trial comparing 3 different wound dressings for the management of partial-thickness skin graft donor sites. J Wound Ostomy Continence Nurs. 2011 Nov-Dec;38(6):643-7. doi: 10.1097/WON.0b013e3182349d2f.
PMID: 22011820
responsible party type: Sponsor
sharing ipd: No