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Tests treatment safety and results for Burns Degree Third
Official title Safety and Efficacy of realSKIN® to Provide Complete Wound Closure of Burn Wounds as an Alternative to Autografting
ClinicalTrials.gov ID: NCT06223269
What this study is testing
What is Skin Xenotransplant?
Skin Xenotransplant is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for burns degree third.
Also referred to as realSKIN®.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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) \ 60% of the total burn area should be FT and DPT) before debridement", and full-thickness burns for which surgical...
- 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
You likely can't join if
- Pregnant or lactating women
- Documented history of infection with human immunodeficiency virus (HIV) or other condition(s) that in the opinion of the Investigator may compromise...
- Immunosuppressive medication regimens e.g. antineoplastics, high dose steroids (\>10 mg prednisone/day), TNF alpha inhibitors, calcineurin inhibitors...
- Active malignancy, including those requiring surgery, chemotherapy, and/or radiation in the past 5 years; non-metastatic basal or squamous cell...
- Use of any experimental or investigational drugs within 30 days prior to placement of realSKIN
- Previously received a porcine or other xenogeneic tissue product, including but not limited to: glutaraldehyde fixed porcine or bovine bioprosthetic...
See the full eligibility 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) \ 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 people 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:
- Hormonal contraceptives (e.g., birth control pills, skin patches, vaginal rings, and the Depo-Provera shot)
- Intrauterine device (IUD)
- Male or female condoms with spermicide
- Diaphragm with spermicide
- Permanent tubal occlusive birth control system
- 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...
- Pregnant or lactating women
- Documented history of infection with human immunodeficiency virus (HIV) or other condition(s) that in the opinion of the Investigator may compromise patient safety or study objectives
- Immunosuppressive medication regimens e.g. antineoplastics, high dose steroids (\>10 mg prednisone/day), TNF alpha inhibitors, calcineurin inhibitors (cyclosporine, tacrolimus), anti- proliferative agents, and other...
- Active malignancy, including those requiring surgery, chemotherapy, and/or radiation in the past 5 years; non-metastatic basal or squamous cell carcinoma of the skin and cervical carcinoma in situ are allowed
- Use of any experimental or investigational drugs within 30 days prior to placement of realSKIN
- Previously received a porcine or other xenogeneic tissue product, including but not limited to: glutaraldehyde fixed porcine or bovine bioprosthetic heart valve replacements and glutaraldehyde fixed porcine dermal...
- Patients with advanced or unstable/uncontrolled comorbid conditions, such as advanced renal disease, diabetes mellitus and liver disease
- Patients with HbA1c ≥ 10.0%; specimen must be obtained for screening purposes if current (within past 3 months) value is not available
- Patients with a history of chronic end stage renal disease defined as MDRD CrCL \< 15mL/min or receiving chronic dialysis
- Patients with a history of chronic liver disease or cirrhosis (Child-Pugh Score C); evidence of acute or chronic hepatitis B infection based on documented HBV serology testing
- Known documented history of Hepatitis B, Hepatitis C, Treponema pallidum, Cytomegalovirus, herpes or varicella zoster; note: Successfully treated hepatitis C patients without evidence of end stage liver disease is...
- Recent (within 3 months prior to study enrollment) MI, unstable angina leading to hospitalization, uncontrolled, CABG, PCI, carotid surgery or stenting, cerebrovascular accident, transient ischemic attack, endovascular...
- Presence of venous or arterial vascular disorder directly affecting the area of burn wound
- Pre-existing haemolytic anemia
- Chronic malnourishment as determined by Investigator
- Inhalation injury as determined by bronchoscopic exam if available, or diagnosis at the time of screening
- Systemic anticoagulation at the time of treatment or INR \> 2
- Documented evidence of wound infection at Screening
- Evidence of sepsis at Screening
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Augusta, Georgia, United States
- Portland, Maine, United States
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Augusta, Georgia, United States; Portland, Maine, United States; Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.