Fish Skin Compared to Cadaver Skin as Temporary Cover for Full Thickness Burns (NCT03984331) | Clinical Trial Compass
CompletedNot Applicable
Fish Skin Compared to Cadaver Skin as Temporary Cover for Full Thickness Burns
United States5 participantsStarted 2019-02-14
Plain-language summary
Objectives and rationale: Optimal burn management involves removing all the dead or burned tissue as early as feasible and cover with an autograft called split thickness skin graft (STSG) taken from the patient. This procedure creates a new wound on the patient and sometimes, when the burn covers very large portion of the patient body, there is a lack of healthy skin to use for this purpose. Under those circumstances, donated cadaver skin is used as a temporary coverage until the patient´s own donor site wound has healed enough to be used again.
The proposed clinical study aims to determine if treatment with fish skin is an alternative to cadaver skin as a temporary coverage for debrided full-thickness burns prior to STSG in terms of autograft take, time to heal, quality of healing (scarring), pain and adverse effects.
Who can participate
Age range
22 Years – 75 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Participant or legally authorized representative is willing and able to give informed consent for participation in the clinical trial.
* Patients from 22 to 75 years of age. Acute full thickness burn wounds outside the following areas; facial, genital and across joints, requiring widely meshed skin grafting or staging of STSG treatment due to insufficient healthy donor sites.
* Maximal Total Body Surface Area (TBSA) of 50% full thickness burns
* Able (in the Investigators opinion) and willing to comply with all clinical trial requirements.
* Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the clinical trial.
Exclusion Criteria:
* Declined consent
* Immunocompromised patients or patients receiving immunosuppressive therapy
* Presently participating in another clinical trial
* Patient actively taking glucocorticoid or cytostatic medications
* Persons with immune deficiency because of disease or iatrogenic-
* Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the clinical trial, or may influence the result of the clinical trial, or the participant's ability to participate in the clinical trial.
* Patient has known allergy to fish. (Shell fish allergy is not a contraindication)
* Exclusion areas are, facial, genital and across joints.
* Female participants who ar…
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.