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

This study has been terminated.
(P.I decided to prematurely end this study.)
Sponsor:
Information provided by (Responsible Party):
Christopher Attinger, M.D., Georgetown University
ClinicalTrials.gov Identifier:
NCT01252836
First received: December 1, 2010
Last updated: May 29, 2013
Last verified: May 2013
  Purpose

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


Condition Intervention Phase
Healing of Donor Site
Pain Level
Device: AWBAT-D
Phase 4

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

Further study details as provided by Georgetown University:

Primary Outcome Measures:
  • Time for donor site to heal with AWBAT-D [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    As compared to current standard of care, Tegaderm.


Secondary Outcome Measures:
  • Pain at donor site [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Pain at donor site is less than that of standard of care treatment, Tegaderm.


Enrollment: 1
Study Start Date: September 2010
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Control
Treatment with Tegaderm
Device: AWBAT-D
Application of AWBAT-D bioengineered device
Experimental: AWBAT-D
Application of AWBAT-D on donor site.
Device: AWBAT-D
Application of AWBAT-D bioengineered device

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01252836

Locations
United States, District of Columbia
Georgetown University Hospital Center for Wound Healing
Washington, District of Columbia, United States, 20007
Sponsors and Collaborators
Georgetown University
Investigators
Principal Investigator: Christopher A Attinger, MD Georgetown University
  More Information

No publications provided

Responsible Party: Christopher Attinger, M.D., Director of Center for Wound Healing, Georgetown University
ClinicalTrials.gov Identifier: NCT01252836     History of Changes
Other Study ID Numbers: 2010-160
Study First Received: December 1, 2010
Last Updated: May 29, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on April 17, 2014