- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01252836
Study Evaluating AWBAT-D Versus the Standard of Care of Split-thickness Skin Graft Donor Sites
December 14, 2016 updated by: Christopher Attinger, M.D., Georgetown University
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
Use of AWBAT-D on split thickness skin graft sites will reduce healing time and pain level.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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District of Columbia
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Washington, District of Columbia, United States, 20007
- Georgetown University Hospital Center for Wound Healing
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subject is 18 years of age or older
- Subjects requiring a split-thickness skin graft with a wound size between 5 and 50cm2 and a depth between 12-18um.
- Ability and willingness to understand and comply with study procedures and to give written informed consent prior to enrollment in the study.
Exclusion Criteria:
- Subjects < 18 years of age
- Subjects with an allergy to porcine products.
- Subjects undergoing STSG with a wound size less than 5 cm2 or greater than 50cm2.
- Subjects undergoing STSG with a wound depth of less than 12um or greater than 18um.
- Subjects undergoing repeat skin graft harvesting at the same donor site.
- 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.
- Subjects participating in any other trials involving the split-thickness skin graft donor site.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Control
Treatment with Tegaderm
|
Application of AWBAT-D bioengineered device
|
Experimental: AWBAT-D
Application of AWBAT-D on donor site.
|
Application of AWBAT-D bioengineered device
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time for donor site to heal with AWBAT-D
Time Frame: 6 weeks
|
As compared to current standard of care, Tegaderm.
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain at donor site
Time Frame: 6 weeks
|
Pain at donor site is less than that of standard of care treatment, Tegaderm.
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Christopher A Attinger, MD, Georgetown University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2010
Primary Completion (Actual)
April 1, 2015
Study Completion (Actual)
April 1, 2015
Study Registration Dates
First Submitted
December 1, 2010
First Submitted That Met QC Criteria
December 2, 2010
First Posted (Estimate)
December 3, 2010
Study Record Updates
Last Update Posted (Estimate)
December 15, 2016
Last Update Submitted That Met QC Criteria
December 14, 2016
Last Verified
December 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- 2010-160
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Data was not collected for use in future research and will not be shared.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Tang-Du HospitalCompletedDisorder of Skin Donor Site | Skin Graft Disorder | Wound Healing Disturbance of
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Rambam Health Care CampusWithdrawnTreatment of Skin Graft Donor SiteIsrael
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Oslo University HospitalUniversity of Oslo; South-Eastern Norway Regional Health AuthorityCompletedRenal Transplant Donor of Left Kidney | Renal Transplant Donor of Right KidneyNorway
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Chulalongkorn UniversityCompletedPain, Intractable | Impaired Wound Healing | Late Complication From Skin Graft | Infection of Skin Donor SiteThailand
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Chulalongkorn UniversityCompletedPain, Intractable | Impaired Wound Healing | Late Complication From Skin Graft | Infection of Skin Donor SiteThailand
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Radboud University Medical CenterMerck Sharp & Dohme LLCCompletedSurgery | Neuromuscular Block | Renal Transplant Donor of Left Kidney | Renal Transplant Donor of Right KidneyNetherlands
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Aubrey Inc.UnknownTreatment of Donor Site BurnsUnited States
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Central Hospital, Nancy, FranceInstitut National de la Santé Et de la Recherche Médicale, France; University...CompletedLiving Donor of KidneyFrance
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University of Maryland, BaltimoreCompletedRobotic Surgery | Renal Transplant Donor of Left Kidney | Donor Nephrectomy | Single-portUnited States
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HaEmek Medical Center, IsraelUnknownDisorder of Skin Donor SiteIsrael
Clinical Trials on AWBAT-D
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Aubrey Inc.TerminatedBurn SurgeryUnited States
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Aubrey Inc.UnknownTreatment of Donor Site BurnsUnited States
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The University of Texas Medical Branch, GalvestonWithdrawn
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Aubrey Inc.Terminated
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Rhode Island HospitalVirtually Better, Inc.CompletedMental Health | Human Immunodeficiency VirusUnited States
-
Lee's Pharmaceutical LimitedUnknownOvarian Epithelial Cancer | Fallopian Tube Cancer | Primary Peritoneal CancerChina
-
Assistance Publique - Hôpitaux de ParisCompletedHealthy VolunteersFrance
-
Royal Prince Alfred Hospital, Sydney, AustraliaCompleted
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GlaxoSmithKlineCompleted