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

• ClinicalTrials.gov Identifier: NCT01562119
• Recruitment Status: Unknown
• First Posted: March 23, 2012
• Last Update Posted: April 19, 2013
• Sponsor: Tang-Du Hospital
• 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
• 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

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

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