Glyaderm Clinical Evaluation Multicenter Study - Full Text View

Purpose

The healing of full thickness skin defects treated with a split thickness skin graft (STSG) is frequently associated with excessive scarring and contraction. The psychological burden of poor cosmesis of these scarred regions as well as functional problems due to skin tightness and decreased joint mobility cause a very significant morbidity in these patients. Application of a dermal substitute underneath the split skin may improve the quality of the scar. Glyaderm is a dermal substitute derived from human skin and due to the elastin in this substitute it will contribute to a long term improvement of pliability and function and a better esthetic outcome.

The main objective is to evaluate the difference in scar quality, after skin restoration of full thickness defects treated with Glyaderm® and STSG versus STSG alone. Secondary objectives are: to evaluate the percentage of Glyaderm® take before application of autografts, to compare healing time and percentage of autograft survival and bacterial load in full thickness defects treated with Glyaderm® and STSG versus STSG alone, and to conduct a concurrent cost-effectiveness and health related quality of life study (i.e. cost utility analysis).

The study is an interventional, prospective, randomized and controlled interactive web based, study in a multicentre setting. Patients with full thickness burn wounds or full thickness skin defects will be evaluated before enrolment. A total of 120 patients will be included.

All included patients will undergo full thickness removal of the burned skin or adequate debridement of all necrotic tissue. The wounds of the patients will be covered with glycerol preserved allografts for wound bed preparation. At the second operation, 5-7 days after the first operation, the allografts are removed. If the wound bed is not suitable for grafting, additional wound bed preparation with allografts is required until the wound bed is satisfactory. If the wound bed is suitable for grafting, the patient is randomized to the Glyaderm® group or the control group. The wounds of the patients randomized to the Glyaderm® group are covered with Glyaderm®. After 6-8 days the wounds are finally covered with a thin STSG. In the control group, the wounds are immediately covered with a thin STSG.

Up to one year after complete wound closure, patients are followed-up for scar evaluation and quality of life.

Condition	Intervention	Phase
Full-thickness Skin Loss Due to Burn, Unspecified Site	Procedure: Glyaderm Procedure: STSG	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Clinical Application of GLYADERM. A Multicentre, Prospective, Randomized Controlled, Comparative Trial of Glyaderm and Split Thickness Skin Graft Versus Split Thickness Skin Graft Alone in Full Thickness Skin Defects

Resource links provided by NLM:

MedlinePlus related topics: Burns Scars

U.S. FDA Resources

Further study details as provided by Euro Tissue Bank:

Primary Outcome Measures:

scar quality [ Time Frame: 12 months after wound closure ] [ Designated as safety issue: No ]
The quality of the scar is measured with objective tools and subjective scar scacles. The elasticity of the scar is measured with the Cutometer® MPA 850 (Courage & Khazaka electronic GmbH) Adapted Vancouver Scar Scale, Patient and Observer Scar Assessment Scale, Ghent contour scale, Tewameter TM 300 for trans epidermal water loss, Corneometer CM 825 for hydration of the stratum corneum, Mexameter MX 18 for erythema and melanin, Reviscometer RVM 600 for the direction of collagen and elastin in the skin Finally a total score is defined.

Secondary Outcome Measures:

percentage of Glyaderm take [ Time Frame: before autograft application (5-7 days after Glyaderm application) ] [ Designated as safety issue: No ]
1. visual assessment of Glyaderm ingrowth

Estimated Enrollment:	120
Study Start Date:	February 2011
Estimated Study Completion Date:	November 2014
Estimated Primary Completion Date:	September 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Glyaderm + STSG All included patients in this arm will undergo full thickness removal of the burned skin or adequate debridement of all necrotic tissue. The wounds of the patients will be covered with glycerol preserved allografts for wound bed preparation. At the second operation, 5-7 days after the first operation, the allografts are removed. If the wound bed is not suitable for grafting, additional wound bed preparation with allografts is required until the wound bed is satisfactory. If the wound bed is suitable for grafting, the wounds of the patients are covered with Glyaderm®. After 6-8 days the wounds are finally covered with a thin STSG.	Procedure: Glyaderm acellular dermis Other Name: dermal substitute
STSG alone All included patients in this arm will undergo full thickness removal of the burned skin or adequate debridement of all necrotic tissue. The wounds of the patients will be covered with glycerol preserved allografts for wound bed preparation. At the second operation, 5-7 days after the first operation, the allografts are removed. If the wound bed is not suitable for grafting, additional wound bed preparation with allografts is required until the wound bed is satisfactory. If the wound bed is suitable for grafting, the wounds are immediately covered with a thin STSG.	Procedure: STSG autologous split skin only Other Name: autologous skin graft

Arms

Assigned Interventions

Experimental: Glyaderm + STSG

All included patients in this arm will undergo full thickness removal of the burned skin or adequate debridement of all necrotic tissue. The wounds of the patients will be covered with glycerol preserved allografts for wound bed preparation. At the second operation, 5-7 days after the first operation, the allografts are removed. If the wound bed is not suitable for grafting, additional wound bed preparation with allografts is required until the wound bed is satisfactory. If the wound bed is suitable for grafting, the wounds of the patients are covered with Glyaderm®. After 6-8 days the wounds are finally covered with a thin STSG.

Procedure: Glyaderm

acellular dermis

Other Name: dermal substitute

STSG alone

All included patients in this arm will undergo full thickness removal of the burned skin or adequate debridement of all necrotic tissue. The wounds of the patients will be covered with glycerol preserved allografts for wound bed preparation. At the second operation, 5-7 days after the first operation, the allografts are removed. If the wound bed is not suitable for grafting, additional wound bed preparation with allografts is required until the wound bed is satisfactory. If the wound bed is suitable for grafting, the wounds are immediately covered with a thin STSG.

Procedure: STSG

autologous split skin only

Other Name: autologous skin graft

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

All clearly full thickness burns or skin defects (TBSA Full Thickness Burn < 30%) as clinically evaluated by two plastic surgeons and/or specialist burn surgeons
Possibility to follow the complete treatment schedule until final graft take and subsequently wound healing and finally participation in the follow-up schedule
Informed consent has been obtained.

Exclusion Criteria:

All partial thickness burns that can heal by conservative treatment
TBSA > 30 %
Study wound < 100 cm² or > 800 cm²
Age of the patient < 18 year
No follow-up until wound closure or withdrawal before start of follow-up
Patient has any condition(s) that seriously compromises the patient's ability to complete this study.
Patient has participated in another study utilizing an investigational drug within the previous 30 days
Patient has one or more medical condition(s), diabetes, including renal, hepatic, hematologic, neurologic, or immune disease that in the opinion of the investigator would make the patient an inappropriate candidate for this study
No informed consent before start of the trial

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01616043

Contacts

Contact: Henk Hoeksema, PT

hendrik.hoeksema@uzgent.be

Locations

Belgium
Hospital Network Antwerp - site Stuivenberg	Recruiting
Antwerp, Belgium
Contact: Cynthia Lafaire, MD
Principal Investigator: Cynthia Lafaire, MD
Sub-Investigator: Lieve de Cuyper, MD
Militairy Hospital neder over heembeek	Recruiting
Brussel, Belgium
Contact: Thomas Rose, MD
Principal Investigator: Thomas Rose, MD
Ghent University Hospital (B)	Recruiting
Gent, Belgium, B 9000
Contact: Stan Monstrey, MD, PhD Stan.Monstrey@Ugent.be
Sub-Investigator: Henk Hoeksema, PT
Greece
General Hospital of Athens "G. Gennimatas" (GR)	Recruiting
Athens, Greece
Contact: Dimosthenes Tsoutsos, MD PhD tsoutsosdimos@yahoo.gr
Sub-Investigator: Eugenia Jenny Kyriopolous, MD
Netherlands
Maasstad Ziekenhuis	Recruiting
Rotterdam, Netherlands
Contact: Jan Doctor, MD
Contact: Magriet Van Baar, PhD
Principal Investigator: Jan Doctor, MD
Sub-Investigator: Margriet Van Baar, PhD
Spain
Hospital Universitari Vall d'Hebron	Recruiting
Barcelona, Spain
Contact: Juan Barret, MD PhD
Principal Investigator: Juan Barret, MD PhD
Sub-Investigator: Jordi Serracanta, MD

Sponsors and Collaborators

Euro Tissue Bank

Dutch Burns Foundation

Investigators

Principal Investigator:

Ali Pirayesh, MD

UZ Gent, Belgium

More Information

No publications provided

Responsible Party:	Euro Tissue Bank
ClinicalTrials.gov Identifier:	NCT01616043 History of Changes
Other Study ID Numbers:	2010/363, B67020108965
Study First Received:	May 29, 2012
Last Updated:	June 7, 2012
Health Authority:	Belgium: Ethics Committee Netherlands: Medical Ethics Review Committee (METC) Greece: Ethics Committee Spain: Ethics Committee

Keywords provided by Euro Tissue Bank:

scar quality

ClinicalTrials.gov processed this record on May 16, 2013