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Completed

NCT Number: NCT01033604

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

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.

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Key information

Conditions

Full Thickness Skin Defects

Age range

Up to 80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Ghent

Ghent, 9000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Glyaderm and split skin graft

Procedure

Full thickness defects treated with Glyaderm and split skin graft.

Split skin graft alone.

Procedure

Full thickness defects treated with split skin graft alone.

Primary outcomes

  1. Comparison of healing time and percentage of autograft survival

    Time frame: After one week

  2. Comparison in bacterial control in full thickness defects

    Time frame: On day 3,5 an 7 post application of Glyaderm

  3. To assess the monitoring of dermal substitute ingrowth with Laser Doppler Imaging

    Time frame: On day 3, 5 and 7 post application of Glyaderm

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Collaborators

  • Dutch Burnwound Foundation, Netherland

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
Dec 16, 2009
Registry last updated
Dec 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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