Glyaderm + Split Thickness Skin Graft Versus Split Thickness Skin Graft Alone in Full Thickness Skin Defects

Clinical Application of a Novel Dermal Substitute Based on Glycerol Preserved Allograft: GLYADERM

The application of Glyaderm for skin restoration intends to provide a more stable wound closure with enhanced pliability and function of the skin and a more favourable scar. The dermal substitute would be affordable for widespread application in full thickness skin defects and burns.

Patients with burn wounds or large full thickness wounds will be evaluated before enrollment. All burn wounds that are not clearly full thickness on clinical assessment will be treated during the first 48 hours with a hydrocolloid paste and covered with a paraffin gauze dressing. This hydrocolloid paste combined with paraffin gauze will ensure maintenance of a moist wound environment for the first 48 hours prior to assessment by LDI and randomization. This is the standard treatment for all burns admitted to the Ghent Burn Centre.

Wounds will be photographed on a daily basis. In order to obtain an optimal preparation for LDI, the burn wounds will be meticulously debrided during dressing changes. LDI is most reliable between 48-72 hours. Patients whose burn wounds meet the inclusion criteria, i.e. full thickness burns with LDI values < 200 will be randomized to receive either GLYADERM and split skin graft versus split skin graft alone.

Study Overview

• Status: Completed
• Conditions: Full Thickness Skin Defects
• Intervention / Treatment: Procedure: Glyaderm and split skin graft; Procedure: Split skin graft alone.

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Ghent, Belgium, 9000
    • University Hospital Ghent

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• All burn wounds with flux values measured by Laser Doppler Imaging, corresponding with an expected healing time longer than 28 days. Dark blue color on the palette of the LDI software with flux values below 200
• All clearly full thickness burns on clinical assessment done by two plastic surgeons and thereafter treated with Flammacerium®.
• Wounds treated with a hydrocolloid paste prior to LDI and with low flux values < 200
• All assessments are done during first days before final decision at day three
• Possibility to follow the complete treatment schedule until final graft take and subsequently wound healing and finally participation on complete follow-up schedule
• Informed consent has been obtained
• TBSA Full Thickness Burn < 40%

Exclusion Criteria:

• All burn wounds with flux values measured by Laser Doppler Imaging, corresponding with faster healing times ( flux values >200 )
• TBSA >40 %
• Not following the complete treatment schedule or missing some evaluations during the follow-up period
• 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
• Patients wish to decline from the 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: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Glyaderm and split skin graft; Full thickness defects treated with Glyaderm and split skin graft.	Procedure: Glyaderm and split skin graft; Full thickness defects treated with Glyaderm and split skin graft.
Active Comparator: Split skin graft alone; Full thickness defects treated with split skin graft alone.	Procedure: Split skin graft alone.; Full thickness defects treated with split skin graft alone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Comparison of healing time and percentage of autograft survival	After one week
Comparison in bacterial control in full thickness defects	On day 3,5 an 7 post application of Glyaderm
To assess the monitoring of dermal substitute ingrowth with Laser Doppler Imaging	On day 3, 5 and 7 post application of Glyaderm

Secondary Outcome Measures

Outcome Measure	Time Frame
To evaluate the functional and cosmetic outcome of skin restoration of full thickness defects treated with Glyaderm and split skin graft versus split skin graft alone	1 month, 3, 6 and 12 months post wound closure
Cost-effectiveness and Health related quality of life (i.e. cost utility analysis)	1 month, 3, 6 and 12 months post wound closure

Collaborators and Investigators

• Sponsor: University Hospital, Ghent
• Collaborators: Dutch Burnwound Foundation, Netherland

Publications and helpful links

Helpful Links

• Website of the University Hospital Ghent

Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: December 15, 2009
• First Submitted That Met QC Criteria: December 15, 2009
• First Posted (Estimate): December 16, 2009

Study Record Updates

• Last Update Posted (Estimate): December 5, 2014
• Last Update Submitted That Met QC Criteria: December 4, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: 2007/033