Glyaderm + Split Thickness Skin Graft Versus Split Thickness Skin Graft Alone in Full Thickness Skin Defects
NCT ID: NCT01033604
Last Updated: 2014-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
31 participants
INTERVENTIONAL
2007-09-30
2012-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Glyaderm and split skin graft
Full thickness defects treated with Glyaderm and split skin graft.
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.
Split skin graft alone.
Full thickness defects treated with split skin graft alone.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
80 Years
ALL
No
Sponsors
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Dutch Burnwound Foundation, Netherland
UNKNOWN
University Hospital, Ghent
OTHER
Responsible Party
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Principal Investigators
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Stan Monstrey, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Ghent
Locations
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University Hospital Ghent
Ghent, , Belgium
Countries
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References
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De Decker I, Hoeksema H, Verbelen J, De Coninck P, Speeckaert M, De Schepper S, Blondeel P, Pirayesh A, Monstrey S, Claes KEY. A single-stage bilayered skin reconstruction using Glyaderm(R) as an acellular dermal regeneration template results in improved scar quality: an intra-individual randomized controlled trial. Burns Trauma. 2023 May 2;11:tkad015. doi: 10.1093/burnst/tkad015. eCollection 2023.
Related Links
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website of the University Hospital Ghent
Other Identifiers
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2007/033
Identifier Type: -
Identifier Source: org_study_id