Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Long Term Evaluation of Human Acellular Dermal Matrix Allograft For Coverage of the Wound After Extensive Deep Burn (ADM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01562119
Recruitment Status : Unknown
Verified April 2013 by Xiaolin Wang,Principal Investigator, Tang-Du Hospital.
Recruitment status was:  Active, not recruiting
First Posted : March 23, 2012
Last Update Posted : April 19, 2013
Sponsor:
Information provided by (Responsible Party):
Xiaolin Wang,Principal Investigator, Tang-Du Hospital

Tracking Information
First Submitted Date March 21, 2012
First Posted Date March 23, 2012
Last Update Posted Date April 19, 2013
Study Start Date January 2011
Estimated Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 17, 2013)
Function of the region covered by human acellular dermal matrix allograft [ Time Frame: March, 2012 to May, 2013 ]
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures
 (submitted: April 17, 2013)
Physical characteristics of the transplanted human acellular dermal matrix allograft [ Time Frame: March, 2012 to May, 2013 ]
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Long Term Evaluation of Human Acellular Dermal Matrix Allograft For Coverage of the Wound After Extensive Deep Burn
Official Title Long Term Evaluation of Human Acellular Dermal Matrix Allograft For Coverage of the Wound After Extensive Deep Burn
Brief Summary The present study was to retrospectively evaluate the long-term outcomes of the cograft acellular dermal matrix (ADM) with autologous thin split-thickness skin for coverage of functional regional wounds in burned patients.
Detailed Description The potential of acellular dermal matrix (ADM) had been proved to improve cosmetic and functional outcomes, nevertheless, there had been few reports about the long term results of the morphological, histological and functional changes after placement. The present study was to retrospectively evaluate the long-term outcomes of the cograft acellular dermal matrix (ADM) with autologous thin split-thickness skin for coverage of functional regional wounds in burned patients.
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
The skin with ADM inplant and the nomal skin as control group
Sampling Method Non-Probability Sample
Study Population Thirty burn patients, treated by composite graft of ADM with autologous split-thickness skin from January 2007 to December 2009, were enrolled in this study.
Condition
  • Burn
  • Traumatic Implants
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Actual Enrollment
 (submitted: March 22, 2012)
30
Original Actual Enrollment Same as current
Estimated Study Completion Date May 2013
Estimated Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • the patient's skin with ADM implant

Exclusion Criteria:

Sex/Gender
Sexes Eligible for Study: All
Ages 3 Years to 52 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT01562119
Other Study ID Numbers TDLL-2012109
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Xiaolin Wang,Principal Investigator, Tang-Du Hospital
Study Sponsor Tang-Du Hospital
Collaborators Not Provided
Investigators
Study Director: Xueyong Li, Doctor Department of Burn and Plastic Sugery
PRS Account Tang-Du Hospital
Verification Date April 2013