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StrataGraft™ Skin Tissue (Human Donor Skin) In The Surgical Management Of Complex Skin Defects

This study has been completed.
Sponsor:
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
Stratatech
ClinicalTrials.gov Identifier:
NCT00618839
First received: February 7, 2008
Last updated: August 8, 2012
Last verified: August 2012
History of Changes
Results First Received: May 8, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Third Degree Burn
Burns
Wound Infection
Degloving Injury
Interventions: Biological: StrataGraft Skin Tissue
Procedure: Cadaver allograft

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study evaluated autograft take and infection in 15 patients with full-thickness skin defects who required sequential surgical procedures. Subjects had surgical excision and temporary placement of StrataGraft and cadaver allograft. The trial was conducted at the University of Wisconsin Hospital and the Arizona Burn Center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All subjects were treated with both StrataGraft and cadaver allograft in a split-wound design. The half-wound sites were randomized to receive StrataGraft or cadaver allograft.

Reporting Groups
  Description
StrataGraft : Cadaver Allograft Wounds were excised and the half-wound sites were randomized to receive StrataGraft skin tissue or cadaver allograft for 7 days until the wounds were ready for autografting.

Participant Flow:   Overall Study
    StrataGraft : Cadaver Allograft  
STARTED     15  
COMPLETED     15  
NOT COMPLETED     0  



  Baseline Characteristics
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Reporting Groups
  Description
StrataGraft : Cadaver Allograft Wounds were excised and the half-wound sites were randomized to receive StrataGraft skin tissue or cadaver allograft for 7 days until the wounds were ready for autografting.

Baseline Measures
    StrataGraft : Cadaver Allograft  
Number of Participants  
[units: participants]
 		  15  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     15  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation 		  43.4  ± 14.7  
Gender  
[units: participants]
 		 
Female     4  
Male     11  
Region of Enrollment  
[units: participants]
 		 
United States     15  



  Outcome Measures
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1.  Primary:   Percent Autograft Take on Wounds Prepared by StrataGraft™ Skin Tissue.   [ Time Frame: two weeks post-autografting ]
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2.  Secondary:   Appearance of Allograft Tissues   [ Time Frame: StrataGraft and cadaver allograft appearance were performed every other day after placement and at the time of allograft removal and the values averaged for each subject. ]
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3.  Secondary:   Viability of Allograft Tissues   [ Time Frame: At the time of allograft removal (~7 days) ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Mary Lokuta
Organization: Stratatech Corporation
phone: 608-441-8358
e-mail: mlokuta@stratatechcorp.com


Publications of Results:


Responsible Party: Stratatech
ClinicalTrials.gov Identifier: NCT00618839     History of Changes
Other Study ID Numbers: STRATA2001, R44AR047499
Study First Received: February 7, 2008
Results First Received: May 8, 2009
Last Updated: August 8, 2012
Health Authority: United States: Food and Drug Administration