NCT01252836

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

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

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Georgetown University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healing of Donor Site
• Pain Level

Interventions

Type	Name	Description
DEVICE	AWBAT-D	Application of AWBAT-D bioengineered device

Timeline

• Start date: 2010-09-01
• Primary completion: 2015-04-01
• Completion: 2015-04-01
• First posted: 2010-12-03
• Last updated: 2016-12-15

Locations

1 site across 1 country: United States