Glyaderm Clinical Evaluation Multicenter Study

August 23, 2016 updated by: Euro Tissue Bank

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
scar quality
Time Frame: 12 months after wound closure
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
percentage of Glyaderm take
Time Frame: before autograft application (5-7 days after Glyaderm application)
1. visual assessment of Glyaderm ingrowth
before autograft application (5-7 days after Glyaderm application)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Euro Tissue Bank

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Dutch Burns Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ali Pirayesh, MD, UZ Gent, Belgium

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 29, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 7, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 11, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 24, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 23, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2010/363
  • B67020108965 (Other Grant/Funding Number: Belgian registration number: B67020108965)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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