CompletedNot Applicable

The Dermisgraft Epithelialization and Late Scar Healing

Sweden23 participantsStarted 2017-02-01

Plain-language summary

Study Synopsis Title; The dermis graft: epithelialization and late scar evaluation A Clinical Prospective multicenter trial Objectives; The objective of this study is to compare a dermal graft with a conventional split thickness skin graft regarding healing quality and scarring. Design; the study is a prospective, controlled clinical multicenter trial. Study population; Atleast 20 burn patients (18-80 years) with a full thickness burn that requires permanent skin cover. Time plan; Enrollment will continue until atleast 20 patients have been included and completed the study.

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: * Thermal \& chemical burns \< 30 % TBSA * Males \& females between 18-80 years old * At least one coherent full thickness wound measuring 15 x 7.5 cm * A minimal of 15 x 7.5 cm coherent undamaged skin located at frontal or lateral side of one of the thighs for graft harvest. Exclusion Criteria: * Patients with severe cutaneous trauma at the same site as the burn injury * Previous burns at the treatment site * Severe cognitive dysfunction or psychiatric disorder * Chronic skin disorder * Chronic use of systemic or local corticosteroid * Chronic use of anticoagulants or platelets * Autoimmune disease * Active hepatitis * Full thickness burns of head, genitalia, axilla or upper third of medial upper arm

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.

What they're measuring

Healing time

Timeframe: 4 weeks

Aesthetic outcome

Timeframe: 12 months

Trial details

NCT IDNCT05189743

SponsorUniversity Hospital, Linkoeping

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-12-31

View on ClinicalTrials.gov More Burns trials