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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 01, 2014