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

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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

Study Description
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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.

Condition or disease
Burn Traumatic Implants

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 Design
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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Long Term Evaluation of Human Acellular Dermal Matrix Allograft For Coverage of the Wound After Extensive Deep Burn
Study Start Date : January 2011
Estimated Primary Completion Date : May 2013
Estimated Study Completion Date : May 2013

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Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Function of the region covered by human acellular dermal matrix allograft [ Time Frame: March, 2012 to May, 2013 ]

Secondary Outcome Measures :
  1. Physical characteristics of the transplanted human acellular dermal matrix allograft [ Time Frame: March, 2012 to May, 2013 ]

Biospecimen Retention:   Samples With DNA
The skin with ADM inplant and the nomal skin as control group

Eligibility Criteria
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Ages Eligible for Study:   3 Years to 52 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • the patient's skin with ADM implant

Exclusion Criteria:

Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01562119


Locations
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China, Shaanxi
Department of Burn and Plastic Sugery, Tangdu Hospital
Xi'an, Shaanxi, China, 710038
Sponsors and Collaborators
Tang-Du Hospital
Investigators
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Study Director: Xueyong Li, Doctor Department of Burn and Plastic Sugery
More Information
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Responsible Party: Xiaolin Wang，Principal Investigator, Ms., Tang-Du Hospital
ClinicalTrials.gov Identifier: NCT01562119    
Other Study ID Numbers: TDLL-2012109
First Posted: March 23, 2012    Key Record Dates
Last Update Posted: April 19, 2013
Last Verified: April 2013
Keywords provided by Xiaolin Wang，Principal Investigator, Tang-Du Hospital:
Burns
Wound repair
Skin substitutes
Additional relevant MeSH terms:
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Burns
Wounds and Injuries