Glyaderm Clinical Evaluation Multicenter Study

This study has been terminated.
(delay in recruitment, lack of additional funding)
Sponsor:
Collaborator:
Dutch Burns Foundation
Information provided by (Responsible Party):
Euro Tissue Bank
ClinicalTrials.gov Identifier:
NCT01616043
First received: May 29, 2012
Last updated: June 6, 2014
Last verified: August 2010
  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:


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


Enrollment: 40
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

  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
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: NCT01616043

Locations
Belgium
Hospital Network Antwerp - site Stuivenberg
Antwerp, Belgium
Militairy Hospital neder over heembeek
Brussel, Belgium
Ghent University Hospital (B)
Gent, Belgium, B 9000
Greece
General Hospital of Athens "G. Gennimatas" (GR)
Athens, Greece
Netherlands
Maasstad Ziekenhuis
Rotterdam, Netherlands
Spain
Hospital Universitari Vall d'Hebron
Barcelona, Spain
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 6, 2014
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 September 18, 2014