A Single-stage Bilayered Skin Reconstruction With Glyaderm® (NCT06249971) | Clinical Trial Compass
CompletedNot Applicable
A Single-stage Bilayered Skin Reconstruction With Glyaderm®
Belgium82 participantsStarted 2017-02-01
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* All deep partial thickness and full-thickness burns as shown by laser Doppler imaging (LDI) and/or clinically evaluated by two plastic surgeons or a burn care coordinator
* Other full-thickness skin defects besides burns, e.g. necrotizing fasciitis, deglovements or phalloplasty donor sites after free flap harvest
* Possibility to follow the complete treatment schedule until final graft take and subsequently wound healing and participation in the follow-up schedule
* Informed consent has been obtained • Age between 18-80 years
Exclusion Criteria:
* All partial-thickness burns that can heal by conservative treatment confirmed by LDI • Not completing the treatment schedule or declining further follow-up • The patient has any condition(s) that seriously compromises the patient's ability to complete this study. • The patient has participated in another study utilizing an investigational drug within the previous 30 days • The patient has one or more medical condition(s) that, in the opinion of the investigator, would make the patient an inappropriate candidate for this study e.g. diabetes, renal or hepatic insufficiency, immune or neurologic disease
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.