Evaluation of ACell Hydrated Wound Dressing for Autogenous Skin Donor Sites (ACell)

July 20, 2015 updated by: United States Army Institute of Surgical Research

The purpose of this study is to see if treating a donor site wound with the ACell dressing is as good as or better than the dressings we currently treat harvested donor sites with. This will be tested on consenting burn patients who require excision and grafting surgery for their burn wounds.

Hypothesis: The mean healing time for wounds treated with the ACell dressing will be less than the mean healing time for wounds treated with the Standard of Care dressing.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

This is a single-center, prospective, randomized, and controlled study to evaluate the effectiveness of the ACell Dressing for use as a dressing for autogenous skin donor sites compared to our current standard donor site dressing, which is currently Xeroform.

Study Type

Interventional

Phase

  • Not Applicable

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

  • United States
    • Texas
      • Fort Sam Houston, Texas, United States, 78234
        • U.S. Army Insitute of Surgical Research

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

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • less than 30% total body surface area burn
  • burn wounds do not involve the donor site harvesting areas
  • requires excision and grafting of sufficient extent to justify two donor site of roughly equal size on non-dependent body surfaces.
  • The scheduled excision and grafting procedure is the first such operation for the subject
  • subject agrees to participate in follow-up evaluations

Exclusion Criteria:

  • Critical illnesses such as those requiring ventilator support, systemic infection, or hemodynamic instability
  • Major acute or chronic medical illness that could affect wound healing
  • Cellulitis or other infection of the potential donor sites
  • Donor site has been previously harvested for grafting
  • Subjects who are pregnant
  • Religious objections or allergy to porcine products

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A
Device: ACell dressing
dressing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The specific aim of this study is to determine if the ACell dressing is superior to the ISR Burn Center's current standard of care dressing with respect to speed of healing, patient comfort or wound cosmesis.
Time Frame: 14 days
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

United States Army Institute of Surgical Research

Investigators

  • Principal Investigator: Michael Albrecht, MD, U.S. army Institute of Surgical Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

November 1, 2006

Primary Completion (Actual)

August 1, 2007

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

July 13, 2006

First Submitted That Met QC Criteria

July 13, 2006

First Posted (Estimate)

July 17, 2006

Study Record Updates

Last Update Posted (Estimate)

July 21, 2015

Last Update Submitted That Met QC Criteria

July 20, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • H-06-002

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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