Glyaderm Clinical Evaluation Multicenter Study

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

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.

Study Overview

• Status: Terminated
• Conditions: Full-thickness Skin Loss Due to Burn, Unspecified Site
• Intervention / Treatment: Procedure: Glyaderm; Procedure: STSG

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: dermal substitute
Other: 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 Names: autologous skin graft

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
scar quality	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.	12 months after wound closure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
percentage of Glyaderm take	1. visual assessment of Glyaderm ingrowth	before autograft application (5-7 days after Glyaderm application)

Collaborators and Investigators

• Sponsor: Euro Tissue Bank
• Collaborators: Dutch Burns Foundation
• Investigators: Principal Investigator: Ali Pirayesh, MD, UZ Gent, Belgium

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: May 29, 2012
• First Submitted That Met QC Criteria: June 7, 2012
• First Posted (Estimate): June 11, 2012

Study Record Updates

• Last Update Posted (Estimate): August 24, 2016
• Last Update Submitted That Met QC Criteria: August 23, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: scar quality
• Other Study ID Numbers: 2010/363; B67020108965 (Other Grant/Funding Number: Belgian registration number: B67020108965)