Glyaderm Clinical Evaluation Multicenter Study

NCT ID: NCT01616043

Last Updated: 2016-08-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2014-11-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Glyaderm

Intervention Type: PROCEDURE

acellular dermis

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.

Group Type: OTHER

STSG

Intervention Type: PROCEDURE

autologous split skin only

Interventions

Glyaderm

acellular dermis

Intervention Type: PROCEDURE

STSG

autologous split skin only

Intervention Type: PROCEDURE

Other Intervention Names

dermal substitute; autologous skin graft

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dutch Burns Foundation

OTHER

Sponsor Role: collaborator

Euro Tissue Bank

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ali Pirayesh, MD

Role: PRINCIPAL_INVESTIGATOR

UZ Gent, Belgium

Locations

Hospital Network Antwerp - site Stuivenberg

Antwerp, , Belgium

Militairy Hospital neder over heembeek

Brussels, , Belgium

Ghent University Hospital (B)

Ghent, , Belgium

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

Athens, , Greece

Maasstad Ziekenhuis

Rotterdam, , Netherlands

Hospital Universitari Vall d'Hebron

Barcelona, , Spain

Countries

Belgium; Greece; Netherlands; Spain

Other Identifiers

B67020108965

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2010/363

Identifier Type: -

Identifier Source: org_study_id