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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified April 2013 by Xiaolin Wang，Principal Investigator, Tang-Du Hospital.
Recruitment status was: Active, not recruiting

Sponsor:

ClinicalTrials.gov Identifier:

NCT01562119

First Posted: March 23, 2012

Last Update Posted: April 19, 2013

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.

Information provided by (Responsible Party):

Xiaolin Wang，Principal Investigator, Tang-Du Hospital

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 Wounds and Injuries

U.S. FDA Resources

Further study details as provided by Xiaolin Wang，Principal Investigator, Tang-Du Hospital:

Primary Outcome Measures:

Function of the region covered by human acellular dermal matrix allograft [ Time Frame: March, 2012 to May, 2013 ]

Secondary Outcome Measures:

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


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

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

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


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


Responsible Party:	Xiaolin Wang，Principal Investigator, Ms., Tang-Du Hospital
ClinicalTrials.gov Identifier:	NCT01562119 History of Changes
Other Study ID Numbers:	TDLL-2012109
First Submitted:	March 21, 2012
First Posted:	March 23, 2012
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:


Burns Wounds and Injuries

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