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

Full Thickness Skin Defects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01033604
• Other study ID #: 2007/033
• Status: Completed
• Phase: N/A
• First received: December 15, 2009
• Last updated: December 4, 2014
• Start date: September 2007
• Est. completion date: December 2012

Study information

• Verified date: December 2014
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: December 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Full Thickness Skin Defects

Intervention

Procedure:
• Glyaderm and split skin graft
Full thickness defects treated with Glyaderm and split skin graft.
• Split skin graft alone.
Full thickness defects treated with split skin graft alone.

Locations

Country	Name	City	State
Belgium	University Hospital Ghent	Ghent

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Ghent	Dutch Burnwound Foundation, Netherland

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of healing time and percentage of autograft survival		After one week	No
Primary	Comparison in bacterial control in full thickness defects		On day 3,5 an 7 post application of Glyaderm	No
Primary	To assess the monitoring of dermal substitute ingrowth with Laser Doppler Imaging		On day 3, 5 and 7 post application of Glyaderm	No
Secondary	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	No
Secondary	Cost-effectiveness and Health related quality of life (i.e. cost utility analysis)		1 month, 3, 6 and 12 months post wound closure	No

External Links

•   website of the University Hospital Ghent