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

Healing of Donor Site Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01252836
• Other study ID #: 2010-160
• Status: Withdrawn
• Phase: Phase 4
• First received: December 1, 2010
• Last updated: December 14, 2016
• Start date: September 2010
• Est. completion date: April 2015

Study information

• Verified date: December 2016
• Source: Georgetown University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healing of Donor Site
• Pain Level

Intervention

Device:
• AWBAT-D
Application of AWBAT-D bioengineered device

Locations

Country	Name	City	State
United States	Georgetown University Hospital Center for Wound Healing	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Georgetown University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time for donor site to heal with AWBAT-D	As compared to current standard of care, Tegaderm.	6 weeks	No
Secondary	Pain at donor site	Pain at donor site is less than that of standard of care treatment, Tegaderm.	6 weeks	No