Study Evaluating AWBAT-D Versus the Standard of Care of Split-thickness Skin Graft Donor Sites

Study Overview
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Brief Summary
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Use of AWBAT-D on split thickness skin graft sites will reduce healing time and pain level.

Detailed Description
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The study is designed as a randomized-controlled trial to examine split thickness skin graft donor wound site healing using AWBAT-D compared to current standard of care: Tegaderm. This will involve randomizing subjects to treatment with the AWBAT-D dressing or Tegaderm and monitoring outcomes. The AWBAT-D device has collagen and we hypothesize that the wounds treated with it will heal faster and with a decreased pain level. The purpose of this study is to evaluate if there are differences in outcomes between AWBAT-D and Tegaderm in healing split thickness skin graft donor sites.

Official Title
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Randomized, Prospective, Pilot Study Evaluating a Temporary Skin Substitute (AWBAT-D) Versus the Standard of Care in the Postoperative Treatment of Split-thickness Skin Graft Donor Sites

Conditions
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Healing of Donor Site, Pain Level

Intervention / Treatment
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* Device: AWBAT-D


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is 18 years of age or older Subjects requiring a split-thickness skin graft with a wound size between 5 and 50cm2 and a depth between 12-18um. Ability and willingness to understand and comply with study procedures and to give written informed consent prior to enrollment in the study. Exclusion Criteria: Subjects < 18 years of age Subjects with an allergy to porcine products. Subjects undergoing STSG with a wound size less than 5 cm2 or greater than 50cm2. Subjects undergoing STSG with a wound depth of less than 12um or greater than 18um. Subjects undergoing repeat skin graft harvesting at the same donor site. Has active malignant disease of any kind. A subject, who has had a malignant disease in the past, was treated and is currently disease-free, may be considered for study entry. Subjects participating in any other trials involving the split-thickness skin graft donor site.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>Treatment with Tegaderm | Device: AWBAT-D<br>* Application of AWBAT-D bioengineered device<br>|
| Experimental: AWBAT-D<br>Application of AWBAT-D on donor site. | Device: AWBAT-D<br>* Application of AWBAT-D bioengineered device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time for donor site to heal with AWBAT-D | As compared to current standard of care, Tegaderm. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain at donor site | Pain at donor site is less than that of standard of care treatment, Tegaderm. | 6 weeks |