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Comparison of Skin Substitutes Used in Burn Care

NCT ID: NCT00676013

Last Updated: 2019-12-16

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

158 participants

Study Classification

INTERVENTIONAL

Study Start Date

1997-12-31

Study Completion Date

2011-01-31

Brief Summary

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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

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

Conditions

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Burns

Keywords

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Burns Skin grafting AlloDerm Integra Homograft Autograft Burn Scar

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Alloderm, Integra, Homograft, Autograft

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

Group Type EXPERIMENTAL

Integra

Intervention Type PROCEDURE

Grafting using the Commercial product Integra as a skin substitute over full thickness burn following excision.

AlloDerm

Intervention Type PROCEDURE

Grafting using the commercial product AlloDerm as a skin substitute

Homograft

Intervention Type PROCEDURE

Grafting using homograft as a skin substitute

Autograft

Intervention Type PROCEDURE

grafting using patients own skin from a separate donor site

Interventions

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Integra

Grafting using the Commercial product Integra as a skin substitute over full thickness burn following excision.

Intervention Type PROCEDURE

AlloDerm

Grafting using the commercial product AlloDerm as a skin substitute

Intervention Type PROCEDURE

Homograft

Grafting using homograft as a skin substitute

Intervention Type PROCEDURE

Autograft

grafting using patients own skin from a separate donor site

Intervention Type PROCEDURE

Other Intervention Names

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Artificial dermis Cadaver skin Cadaver Skin

Eligibility Criteria

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Inclusion Criteria

* Burn injury requiring grafting
* 0 years-90 years

Exclusion Criteria

* Partial thickness burns only
Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Texas Medical Branch, Galveston

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David N Herndon, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas

Locations

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University of Texas Medical Branch, Galveston

Galveston, Texas, United States

Site Status

University of Texas Medical Branch

Galveston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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97-286

Identifier Type: -

Identifier Source: org_study_id