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

Tracking Information

First Received Date ^ICMJE

October 18, 1999

Last Updated Date

June 23, 2005

Start Date ^ICMJE

October 1999

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00004413 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Brief Summary

OBJECTIVES:

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

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.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Efficacy Study

Condition ^ICMJE

Burns

Intervention ^ICMJE

Procedure: Skin graft

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

up to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00004413

Responsible Party

Study ID Numbers ^ICMJE

199/13305, UCMC-FDR000672, UCMC-IDE-G980023

Study Sponsor ^ICMJE

FDA Office of Orphan Products Development

Collaborators ^ICMJE

University of Cincinnati

Investigators ^ICMJE

Study Chair:

Steven T. Boyce

University of Cincinnati

Information Provided By

FDA Office of Orphan Products Development

Verification Date

January 2000

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP