Actively Recruiting
Safety and Efficacy of realSKIN® to Provide Complete Wound Closure of Burn Wounds as an Alternative to Autografting
Led by XenoTherapeutics, Inc. · Updated on 2025-04-02
50
Participants Needed
4
Research Sites
86 weeks
Total Duration
On this page
Sponsors
X
XenoTherapeutics, Inc.
Lead Sponsor
J
Joseph M. Still Research Foundation, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety and Efficacy of realSKIN® to Provide Complete Wound Closure of Burn Wounds as an Alternative to Autografting
Who Can Participate
Eligibility Criteria
You may qualify if you...
- The subject or their legally authorized representative provides written informed consent
- Males or females aged 18 years or older
- Total burn surface area less than 50% including primarily full-thickness and deep-partial thermal burns before debridement
- Mixed depth thermal burn wounds including full thickness requiring skin grafting
- Biological females must have a negative pregnancy test at screening and must not be nursing
- Agree to use an approved method of contraception for at least 3 months after realSKIN placement
- Sufficient burn wound area for both realSKIN and autograft placement, excluding face, hands, joints, weight-bearing areas, or inguinal region
You will not qualify if you...
- Pregnant or lactating women
- History of HIV infection or other conditions compromising safety or study goals
- Use of immunosuppressive medications such as high dose steroids, antineoplastics, TNF alpha inhibitors, calcineurin inhibitors, or other immunomodulators
- Active malignancy requiring recent treatment, except certain skin or cervical carcinomas
- Use of investigational drugs within 30 days before realSKIN placement
- Prior receipt of porcine or other xenogeneic tissue products
- Advanced or unstable comorbid conditions including renal disease, diabetes, liver disease
- HbA1c greater than or equal to 10.0%
- History of end-stage renal disease or chronic dialysis
- History of chronic liver disease or cirrhosis Child-Pugh C; acute or chronic hepatitis B infection
- Known history of Hepatitis B, C, syphilis, CMV, herpes or varicella zoster
- Recent serious cardiovascular events or planned major surgeries
- Presence of vascular disorders affecting burn area
- Pre-existing hemolytic anemia
- Chronic malnourishment
- Inhalation injury
- Systemic anticoagulation or INR greater than 2 at treatment
- Evidence of wound infection or sepsis at screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Arizona Burn Center Valleywise Health
Phoenix, Arizona, United States, 85008
Actively Recruiting
2
JMS Burn Center at Doctors Hospital
Augusta, Georgia, United States, 30909
Actively Recruiting
3
MaineHealth Maine Medical Center
Portland, Maine, United States, 04102
Not Yet Recruiting
4
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Not Yet Recruiting
Research Team
J
Jon Adkins, MBA
CONTACT
K
Kaitlyn Rogers, PhD(C)
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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