Phase II Randomized Study of Cultured Skin Substitutes Versus Split Thickness Skin Grafts in Patients With Severe Burn Injuries

This study is currently recruiting participants.

Verified by FDA Office of Orphan Products Development, January 2000

First Received: October 18, 1999 Last Updated: June 23, 2005 History of Changes

Sponsors and Collaborators:	FDA Office of Orphan Products Development University of Cincinnati
Information provided by:	FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:	NCT00004413

Purpose

OBJECTIVES:

I. Determine the safety and efficacy of biosynthetic skin substitute as a routine therapy for treatment of severe burn injuries.

Condition	Intervention	Phase
Burns	Procedure: Skin graft	Phase II

MedlinePlus related topics: Burns

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Efficacy Study

Further study details as provided by FDA Office of Orphan Products Development:

Study Start Date:

October 1999

Detailed Description:

PROTOCOL OUTLINE: This is a randomized study. Two wound sites of similar area and depth are selected on each patient to receive the study treatments. One site is randomized to receive cultured skin substitute (CSS) grafts and the other receives split-thickness skin grafts (STSG). Prior to randomization all wounds are treated according to prevailing standards of burn care. CSS and STSG are surgically applied approximately 21 to 28 days after a thin split thickness autograft is harvested to prepare CSS grafts. Each wound is excised and irrigated prior to the application of either CSS or STSG.

Patients are followed for at least 1 year after treatment.

Eligibility

Ages Eligible for Study:	up to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Thermal burns that require skin grafts 3 or more weeks after admission to the hospital
Not pregnant

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004413

Locations

United States, Ohio
Shriners Burns Hospital	Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Steven T. Boyce 513-872-6080
University of Cincinnati Medical Center	Recruiting
Cincinnati, Ohio, United States, 45267-0562
Contact: Steven T. Boyce 513-872-6080

Sponsors and Collaborators

FDA Office of Orphan Products Development

University of Cincinnati

Investigators

Study Chair:

Steven T. Boyce

University of Cincinnati

More Information

No publications provided

Study ID Numbers:	199/13305, UCMC-FDR000672, UCMC-IDE-G980023
Study First Received:	October 18, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00004413 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by FDA Office of Orphan Products Development:

burns
dermatologic disorders
rare disease

Study placed in the following topic categories:

Burns
Skin Diseases
Rare Diseases

ClinicalTrials.gov processed this record on May 07, 2009