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

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Xiaolin Wang，Principal Investigator, Tang-Du Hospital

ClinicalTrials.gov Identifier:

NCT01562119

First received: March 21, 2012

Last updated: April 17, 2013

Last verified: April 2013

History of Changes

Purpose

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
Burn Traumatic Implants


Study Type:	Observational
Study Design:	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

Resource links provided by NLM:

MedlinePlus related topics: Burns

U.S. FDA Resources

Further study details as provided by Tang-Du Hospital:

Primary Outcome Measures:

Function of the region covered by human acellular dermal matrix allograft [ Time Frame: March, 2012 to May, 2013 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Physical characteristics of the transplanted human acellular dermal matrix allograft [ Time Frame: March, 2012 to May, 2013 ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples With DNA

The skin with ADM inplant and the nomal skin as control group


Enrollment:	30
Study Start Date:	January 2011
Estimated Study Completion Date:	May 2013
Estimated Primary Completion Date:	May 2013 (Final data collection date for primary outcome measure)

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.

Eligibility


Ages Eligible for Study:	3 Years to 52 Years
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01562119

Locations


China, Shaanxi
Department of Burn and Plastic Sugery, Tangdu Hospital
Xi'an, Shaanxi, China, 710038

Sponsors and Collaborators

Tang-Du Hospital

Investigators


Study Director:	Xueyong Li, Doctor	Department of Burn and Plastic Sugery

More Information

No publications provided


Responsible Party:	Xiaolin Wang，Principal Investigator, Ms., Tang-Du Hospital
ClinicalTrials.gov Identifier:	NCT01562119 History of Changes
Other Study ID Numbers:	TDLL-2012109
Study First Received:	March 21, 2012
Last Updated:	April 17, 2013
Health Authority:	China: Ministry of Health

Keywords provided by Tang-Du Hospital:


Burns Wound repair Skin substitutes

ClinicalTrials.gov processed this record on March 03, 2015

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