NCT04589442 Microsurfaced Grafts in Deep Burn Wounds
| NCT ID | NCT04589442 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | CellTherX |
| Condition | Burns |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2021-01-04 |
| Primary Completion | 2021-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 20 participants in total. It began in 2021-01-04 with a primary completion date of 2021-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study is designed as a prospective, randomized, within subject controlled design to evaluate the effectiveness of Microsurfaced vs Control cadaveric grafts for coverage of acute deep-partial or full-thickness burn wounds to promote wound healing. This study will be performed in 2 parts: Time to wound bed preparedness through 6 weeks (Part A) and wound site healing, graft take and long-term scar outcomes (Part B). Subjects will be treated with both control and microsurfaced cadaveric grafts on adjacent deep-partial or full-thickness burn wounds.
Eligibility Criteria
Inclusion Criteria: * Signed informed consent by patient or Legally Authorized Representative (LAR) * Subject with deep partial or full thickness burn injury due to flame burn, scald injury or contact burn * Study burn site large enough to accommodate placement of control and microsurfaced cadaveric graft (minimum 4 cm2 each) at the same location OR 2 study burn sites large enough to each accommodate control and microsurfaced cadaveric graft, respectively at minimum 4 cm2. * Total Body Surface Area burned (TBSA) total ≤30 % * Admission within 72 hours of burn injury * Non-infected wound as diagnosed by the attending physician upon admission * Treated as an outpatient or in an observational setting * 21 years of age or older Exclusion Criteria: * Burns involving the face * Causes other than contact burn, flame or scald injuries (i.e., electrical, chemical or frostbite) * Admission time greater than 72 hours after the injury * Wounds noted to be infected at admission * Is pregnant or plans to become pregnant * Is nursing or actively lactating * Developmental disability/significant psychological disorder that in the opinion of the investigator could impair the subject's ability to provide informed consent, participate in the study protocol or record study measures, including untreated schizophrenia, bipolar disorder and psychiatric hospitalization within the last 2 years. * Active alcohol or substance abuse in the opinion of the investigator that could impair the subject's participation in the study protocol or record study materials * Any medical condition or co-morbidity that in the opinion of the investigator, would prevent successful participation in the study
Contact & Investigator
Claus Brandigi, MD
PRINCIPAL INVESTIGATOR
Joseph M Still Research Foundation
Frequently Asked Questions
Who can join the NCT04589442 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, studying Burns. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04589442 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT04589442 currently recruiting?
Yes, NCT04589442 is actively recruiting participants. Contact the research team at joan.wilson@jmsreserachfoundation.org for enrollment information.
Where is the NCT04589442 trial being conducted?
This trial is being conducted at Augusta, United States.
Who is sponsoring the NCT04589442 clinical trial?
NCT04589442 is sponsored by CellTherX. The principal investigator is Claus Brandigi, MD at Joseph M Still Research Foundation. The trial plans to enroll 20 participants.