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

Phase 4

Withdrawn

• Conditions: Healing of Donor Site; Pain Level
• Interventions: Device: AWBAT-D

• Registration Number: NCT01252836
• Lead Sponsor: Georgetown University

Brief Summary

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

Detailed Description

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 Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-12-01
• Study First Submitted QC: 2010-12-02
• Study First Posted: 2010-12-03
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-14
• Last Update Posted: 2016-12-15

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AWBAT-D	AWBAT-D	Application of AWBAT-D on donor site.
Control	AWBAT-D	Treatment with Tegaderm

Primary Outcome Measures

Name	Time	Method
Time for donor site to heal with AWBAT-D	6 weeks	As compared to current standard of care, Tegaderm.

Secondary Outcome Measures

Name	Time	Method
Pain at donor site	6 weeks	Pain at donor site is less than that of standard of care treatment, Tegaderm.

Trial Locations

Locations (1)

Georgetown University Hospital Center for Wound Healing; 🇺🇸 Washington, District of Columbia, United States