Glyaderm Clinical Evaluation Multicenter Study

NCT01616043 | Terminated Phase 3

• 2 other identifiers: 2010/363B67020108965
• Study Type: interventional
• Target: 40
• Locations: 4 countries
• Sites: 6

Brief Summary

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.

Conditions

Full-thickness Skin Loss Due to Burn, Unspecified Site

Keywords

scar quality

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• percentage of Glyaderm take

  before autograft application (5-7 days after Glyaderm application)

Study Arms (2)

Glyaderm + STSG

EXPERIMENTAL

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

STSG alone

OTHER

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

Interventions

Glyaderm PROCEDURE

acellular dermis

Also known as: dermal substitute

Glyaderm + STSG

STSG PROCEDURE

autologous split skin only

Also known as: autologous skin graft

STSG alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Euro Tissue Bank: lead
• Dutch Burns Foundation: collaborator

Study Sites (6)

Hospital Network Antwerp - site Stuivenberg

Antwerp, Belgium

Location

Militairy Hospital neder over heembeek

Brussels, Belgium

Location

Ghent University Hospital (B)

Ghent, B 9000, Belgium

Location

General Hospital of Athens "G. Gennimatas" (GR)

Athens, Greece

Location

Maasstad Ziekenhuis

Rotterdam, Netherlands

Location

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Location

Study Officials

• Ali Pirayesh, MD

  UZ Gent, Belgium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2012
• First Posted: June 11, 2012
• Study Start: February 1, 2011
• Primary Completion: September 1, 2014
• Study Completion: November 1, 2014
• Last Updated: August 24, 2016

Record last verified: 2016-08

Locations

GR (1); ES (1); BE (3); NL (1)