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

NCT ID: NCT01252836

Last Updated: 2016-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2015-04-30

Brief Summary

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

Detailed Description

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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

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Healing of Donor Site Pain Level

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Control

Treatment with Tegaderm

Group Type PLACEBO_COMPARATOR

AWBAT-D

Intervention Type DEVICE

Application of AWBAT-D bioengineered device

AWBAT-D

Application of AWBAT-D on donor site.

Group Type EXPERIMENTAL

AWBAT-D

Intervention Type DEVICE

Application of AWBAT-D bioengineered device

Interventions

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AWBAT-D

Application of AWBAT-D bioengineered device

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Georgetown University

OTHER

Sponsor Role lead

Responsible Party

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Christopher Attinger, M.D.

Director of Center for Wound Healing

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christopher A Attinger, MD

Role: PRINCIPAL_INVESTIGATOR

Georgetown University

Locations

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Georgetown University Hospital Center for Wound Healing

Washington D.C., District of Columbia, United States

Site Status

Countries

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United States

Other Identifiers

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2010-160

Identifier Type: -

Identifier Source: org_study_id