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A Single-stage Bilayered Skin Reconstruction With Glyaderm®

NCT06249971 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2024-02-08

No results posted yet for this study

Summary

The study will explore the potential of utilizing Glyaderm® in a single-stage engrafting process, aiming for a more cost-effective approach. While the absence of the reticular dermal layer is a challenge associated with autologous split-thickness skin grafting (STSG), often leading to hypertrophic scars and contractures, various dermal substitutes with inconsistent results exist. Bilayered skin reconstruction using glycerolized acellular dermis (Glyaderm®) has shown promise in improving scar quality through a two-step procedure. However, unlike the typical two-step process required for most dermal substitutes, our investigation focuses on the cost-effective application of Glyaderm® in a single-stage engrafting. This approach, if successful, could offer advantages such as reduced costs, shorter hospitalization times, and lower infection rates-attributes preferred by many surgeons, especially when autografts are available.

Conditions

  • Burns
  • Full Thickness Burn
  • Necrotizing Fascitis

Interventions

PROCEDURE

Dermal subsitute Glyaderm + skin graft

A human donor-derived dermal substitute will be implanted together with a skin graft

PROCEDURE

Skin graft alone

Skin graft alone with no dermal substitute

Sponsors & Collaborators

  • Research Foundation Flanders

    collaborator OTHER

  • University Hospital, Ghent

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-01
Primary Completion
2021-09-30
Completion
2021-09-30

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06249971 on ClinicalTrials.gov