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

Georgetown University

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Conditions

Healing of Donor Site Pain Level

Interventions

AWBAT-DDEVICE

Application of AWBAT-D bioengineered device

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Subject is 18 years of age or older 2. Subjects requiring a split-thickness skin graft with a wound size between 5 and 50cm2 and a depth between 12-18um. 3. Ability and willingness to understand and comply with study procedures and to give written informed consent prior to enrollment in the study. Exclusion Criteria: 1. Subjects \< 18 years of age 2. Subjects with an allergy to porcine products. 3. Subjects undergoing STSG with a wound size less than 5 cm2 or greater than 50cm2. 4. Subjects undergoing STSG with a wound depth of less than 12um or greater than 18um. 5. Subjects undergoing repeat skin graft harvesting at the same donor site. 6. 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. 7. Subjects participating in any other trials involving the split-thickness skin graft donor site.

Locations (1)

Georgetown University Hospital Center for Wound Healing

Washington D.C., District of Columbia, United States

Outcomes

Primary Outcomes

Time for donor site to heal with AWBAT-D

As compared to current standard of care, Tegaderm.

Time frame: 6 weeks

Secondary Outcomes

Pain at donor site

Pain at donor site is less than that of standard of care treatment, Tegaderm.

Time frame: 6 weeks

Data from ClinicalTrials.gov

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