NCT01033604

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: University Hospital, Ghent · Academic / Other
• Sex: All
• Age: 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Full Thickness Skin Defects

Interventions

Type	Name	Description
PROCEDURE	Glyaderm and split skin graft	Full thickness defects treated with Glyaderm and split skin graft.
PROCEDURE	Split skin graft alone.	Full thickness defects treated with split skin graft alone.

Timeline

• Start date: 2007-09-01
• Primary completion: 2012-02-01
• Completion: 2012-12-01
• First posted: 2009-12-16
• Last updated: 2014-12-05

Locations

1 site across 1 country: Belgium