← Back to Search

Skin Xenotransplant

Skin Xenotransplant for Wound Healing

Phase 3

Waitlist Available

Led By Bounthavy Homsombath, MD

Research Sponsored by XenoTherapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Biological females must have a negative serum pregnancy test at Screening and must not be nursing

Timeline

Screening 3 weeks

Treatment Varies

Follow Up post-treatment month 4 (± 1 month)

Awards & highlights

Study Summary

This trial will test the safety and effectiveness of realSKIN® in treating deep burns. It aims to see if realSKIN® can fully close the wounds without the need for autografting

Who is the study for?

This trial is for individuals with mixed-depth, full-thickness burn wounds. It's designed to see if realSKIN® can help heal these burns as an alternative to the standard treatment of autografting, where a patient's own skin is used.Check my eligibility

What is being tested?

The study tests the safety and effectiveness of realSKIN®, a new potential treatment for serious burns, against autografting. Participants will be assigned to receive either realSKIN® or undergo traditional autograft surgery.See study design

What are the potential side effects?

Potential side effects may include reactions at the wound site, infection risks associated with skin grafts, and possible complications related to wound healing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

Less than half of my body has severe burns needing surgery.

Select...

I am not pregnant or breastfeeding.

Select...

I have a severe burn that needs skin grafting.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ post-treatment month 4 (± 1 month)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~post-treatment month 4 (± 1 month)

This trial's timeline: 3 weeks for screening, Varies for treatment, and post-treatment month 4 (± 1 month) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Percent Area of Treatment Sites Autografted

Secondary outcome measures

Exploratory Endpoint: Evaluate realSKIN treatment sites for the existence of residual porcine cell populations at Post-Treatment Month 4 (± 1 month).

Pain at the Patient Skin Harvest Sites

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Skin XenotransplantExperimental Treatment1 Intervention

After surgical preparation of the wound beds, subjects will receive approximately 150 square centimeters of realSKIN® at one site, and autograft at the other site, per the standard of care, in accordance with the randomization schedule.

Group II: AutograftActive Control1 Intervention

The comparator control for the study is autografting: the current standard of care procedure for the treatment of severe burns involves the removal of a sheet of healthy skin from an uninjured site on the patient and using it to cover the original burn wound to achieve complete and durable wound closure.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Joseph M. Still Research Foundation, Inc.OTHER

8 Previous Clinical Trials

308 Total Patients Enrolled

1 Trials studying Wound Healing

93 Patients Enrolled for Wound Healing

XenoTherapeutics, Inc.Lead Sponsor

1 Previous Clinical Trials

25 Total Patients Enrolled

Bounthavy Homsombath, MDPrincipal InvestigatorJMS BURN CENTER AT DOCTORS HOSPITAL OF AUGUSTA

1 Previous Clinical Trials

30 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any current opportunities for potential participants to enroll in this trial?

"As per the information provided on clinicaltrials.gov, this particular trial is no longer actively seeking participants. The listing was posted on January 10th, 2024 and last updated on January 22nd, 2024. However, it's worth noting that there are currently 873 other trials enrolling participants at this time."

Answered by AI

What level of risk does Skin Xenotransplantation pose to individuals seeking treatment?

"Based on our assessment, the safety of Skin Xenotransplant in this Phase 3 trial is considered to be at a level of 3. This rating signifies that there exists supporting evidence for both efficacy and multiple rounds of data showcasing its safety profile."

Answered by AI

Are numerous medical facilities within the United States conducting this trial?

"This clinical trial is being conducted at four different sites, including Madison, Augusta, and Boston. There are also an additional four locations where the study is taking place. It would be beneficial for participants to choose a site that is close to their location in order to minimize travel requirements."

Answered by AI

Recent research and studies

Wound Repair and RegenerationJournal

Human Skin Wounds: A Major and Snowballing Threat to Public Health and the Economy

Sen, Chandan K., Gayle M. Gordillo, Sashwati Roy, Robert Kirsner, Lynn Lambert, Thomas K. Hunt, Finn Gottrup, Geoffrey C. Gurtner, and Michael T. Longaker. 2009. “Human Skin Wounds: A Major and Snowballing Threat to Public Health and the Economy”. Wound Repair and Regeneration. Wiley. doi:10.1111/j.1524-475x.2009.00543.x.

clinicaltrials.govStudy

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

2024. "Safety and Efficacy of realSKIN® to Provide Complete Wound Closure of Burn Wounds as an Alternative to Autografting". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06223269.