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

Georgetown University

Status and phase: Withdrawn; Phase 4

Conditions: Pain Level; Healing of Donor Site

Treatments: Device: AWBAT-D

Study type: Interventional

Funder types: Other

Identifiers

NCT01252836

2010-160

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

Treatment with Tegaderm

Treatment:

Device: AWBAT-D

AWBAT-D

Experimental group

Description:

Application of AWBAT-D on donor site.

Treatment:

Device: AWBAT-D