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Clinical Trials/NL-OMON29090
NL-OMON29090
Not yet recruiting
Not Applicable

A multicenter randomized controlled trial assessing and comparing long-term scar quality after micrografting versus mesh grafting of deep dermal burns

niversity Hospital Ghent, Belgium0 sites70 target enrollmentTBD

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
patients with clinically deep burn or deep skin defect between 4% and 20% TBSA
Sponsor
niversity Hospital Ghent, Belgium
Enrollment
70
Status
Not yet recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
niversity Hospital Ghent, Belgium

Eligibility Criteria

Inclusion Criteria

  • Patients \=18 years
  • Clinically deep burn or deep skin defect between 4% and 20% TBSA
  • Patients with two comparable deep partial thickness and/or full thickness burns, confirmed by laser Doppler imaging (LDI) or deep skin defects, of minimum 1:2 plissee \= 36cm², requiring surgery after assessment by a (plastic) surgeon/burn physician
  • Patients who are mentally capable to give legal consent or legal representative when the patient is temporarily incompetent (e.g. patient is sedated/ventilated)

Exclusion Criteria

  • Patient has participated in another study utilizing an investigational drug or device within the previous 30 days
  • Wounds covering face, hands or joints
  • Patient has one or more medical condition(s) that in the opinion of the treating physician would make the patient an inappropriate candidate for this study
  • Patients who are expected (according to the responsible medical doctor) to be non\-compliant to the study protocol. (This includes patients with severe cognitive dysfunction/impairment and severe psychiatric disorders).

Outcomes

Primary Outcomes

Not specified

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