Evaluation of ACell Hydrated Wound Dressing for Autogenous Skin Donor Sites

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WITHDRAWN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

NA

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2007-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Burns

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Group Type ACTIVE_COMPARATOR

ACell dressing

Intervention Type DEVICE

dressing

Interventions

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ACell dressing

dressing

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No