RecruitingPhase 3

Safety and Efficacy of realSKIN® to Provide Complete Wound Closure of Burn Wounds as an Alternative to Autografting

United States50 participantsStarted 2024-05-09

Plain-language summary

To evaluate the safety and efficacy of realSKIN® to provide complete wound closure of mixed-depth, full-thickness burn wounds as an alternative treatment to autografting.

Who can participate

Age range

18 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

. The subject, or the subject's legally authorized representative (LAR), provides written informed consent to participate in this study
. Males or females age greater than or equal to 18 years old
. Total Burn Surface Area (TBSA) \<50% to include mixed depth and full-thickness burn wounds as defined as "primarily full-thickness (FT) and deep-partial (DPT) thermal burns (e.g. \>60% of the total burn area should be FT and DPT) before debridement", and full-thickness burns for which surgical intervention is clinically indicated
. Having a mixed depth thermal burn wound including full thickness requiring skin grafting
. Biological females must have a negative serum pregnancy test at Screening and must not be nursing
. All subjects must agree to use a protocol-approved method of contraception for a minimum of 3 months following realSKIN placement, which includes a barrier method plus one or more of the following:
. Sufficient area of burn wound for realSKIN and comparator autograft placement to not be located on face or hands or having a target graft site centered on high-impact areas such as joints, weight-bearing areas (e.g. soles of feet), or the inguinal region, per Investigator's judgment

Exclusion criteria

. Pregnant or lactating women

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

Incidence of Complete Wound Closure at Post-Treatment Day 28 (± 7 days)

Timeframe: Post-Treatment Day 28 (± 7 days)

Percent Area of Treatment Sites Autografted

Timeframe: Post-Treatment Month 4 (± 1 month)

Trial details

NCT IDNCT06223269

SponsorXenoTherapeutics, Inc.

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12

Contact for this trial

Jon Adkins, MBA

6179397893 clinicaltrials@xenotx.org

View on ClinicalTrials.gov More Burns Degree Third trials