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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Dutch Burnwound Foundation, Netherland
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT01033604
First received: December 15, 2009
Last updated: July 27, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention
Full Thickness Skin Defects
Procedure: Glyaderm and split skin graft
Procedure: Split skin graft alone.

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Application of a Novel Dermal Substitute Based on Glycerol Preserved Allograft: GLYADERM

Resource links provided by NLM:


Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • Comparison of healing time and percentage of autograft survival [ Time Frame: After one week ] [ Designated as safety issue: No ]
  • Comparison in bacterial control in full thickness defects [ Time Frame: On day 3,5 an 7 post application of Glyaderm ] [ Designated as safety issue: No ]
  • To assess the monitoring of dermal substitute ingrowth with Laser Doppler Imaging [ Time Frame: On day 3, 5 and 7 post application of Glyaderm ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: 1 month, 3, 6 and 12 months post wound closure ] [ Designated as safety issue: No ]
  • Cost-effectiveness and Health related quality of life (i.e. cost utility analysis) [ Time Frame: 1 month, 3, 6 and 12 months post wound closure ] [ Designated as safety issue: No ]

Enrollment: 31
Study Start Date: September 2007
Estimated Study Completion Date: December 2012
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   up to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01033604

Locations
Belgium
University Hospital Ghent
Ghent, Belgium, 9000
Sponsors and Collaborators
University Hospital, Ghent
Dutch Burnwound Foundation, Netherland
Investigators
Principal Investigator: Stan Monstrey, MD, PhD University Hospital, Ghent
  More Information

Additional Information:
No publications provided

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT01033604     History of Changes
Other Study ID Numbers: 2007/033
Study First Received: December 15, 2009
Last Updated: July 27, 2012
Health Authority: Belgium: Institutional Review Board

ClinicalTrials.gov processed this record on April 17, 2014