Comparison of Skin Substitutes Used in Burn Care

Not Applicable

Terminated

• Conditions: Burns
• Interventions: Procedure: Integra; Procedure: AlloDerm; Procedure: Homograft; Procedure: Autograft

• Registration Number: NCT00676013
• Lead Sponsor: The University of Texas Medical Branch, Galveston

Brief Summary

The purpose of this study is to determine if using a DERMAL LAYER under skin grafts:

1. will reduce scar formation of skin grafts

2. will reduce burn wound contractures

3. will improve functional outcome of joints requiring grafts

Compare scarring outcome of Dermal products

Detailed Description

Various skin substitutes are compared for healing, scar and functional and cosmetic outcomes.

Study Timeline

• Study Start: 1997-12
• Study First Submitted: 2007-12-26
• Study First Submitted QC: 2008-05-07
• Study First Posted: 2008-05-12
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Results First Submitted: 2012-08-06
• Status Verified: 2018-08
• Results First Submitted QC: 2019-11-26
• Last Update Submitted: 2019-11-26
• Results First Posted: 2019-12-16
• Last Update Posted: 2019-12-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 158

Inclusion Criteria

• Burn injury requiring grafting
• 0 years-90 years

Exclusion Criteria

• Partial thickness burns only

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Alloderm, Integra, Homograft, Autograft	Homograft	Burn debridement and grafting using interventions of 1) AlloDerm, 2) Integra, 3) Homograft and 4) Autograft on four separate sites on each patient
Alloderm, Integra, Homograft, Autograft	AlloDerm	Burn debridement and grafting using interventions of 1) AlloDerm, 2) Integra, 3) Homograft and 4) Autograft on four separate sites on each patient
Alloderm, Integra, Homograft, Autograft	Autograft	Burn debridement and grafting using interventions of 1) AlloDerm, 2) Integra, 3) Homograft and 4) Autograft on four separate sites on each patient
Alloderm, Integra, Homograft, Autograft	Integra	Burn debridement and grafting using interventions of 1) AlloDerm, 2) Integra, 3) Homograft and 4) Autograft on four separate sites on each patient

Primary Outcome Measures

Name	Time	Method
Burn Scar Comparison	2 years post burn injury	Burn scar is measured scar using the Vancouver Scar Scale (range 0-12) for each of the various skin substitutes used in grafting. Vancouver Scar Scale measure burn scarring assessing categories of redness/vascularity, hardness, pigmentation and scar height. Each item has a scale of 0-3. Score for each category is summed together for a total score between 0-12. The total score is generally used in the burn community, therefore the total score will be reported. Lower scores are better; higher scores are worse.

Trial Locations

Locations (2)

University of Texas Medical Branch; 🇺🇸 Galveston, Texas, United States

University of Texas Medical Branch, Galveston; 🇺🇸 Galveston, Texas, United States