Using microsurfaced grafts to treat deep burn wounds

A Prospective, Randomized Study to Evaluate the Effectiveness of Microsurfaced vs Control Cadaveric Decellularized Grafts to Establish Wound Bed Preparedness in Deep Partial and Full Thickness Burn Wounds

This study is testing if special skin grafts from donors can heal deep burn wounds better than regular grafts for people with serious burn injuries.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 21 Years and up
• Sex: All
• Sponsor: CellTherX (Industry-sponsored)
• Locations: 1 site (Augusta, Georgia)
• Trial ID: NCT04589442 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of microsurfaced cadaveric grafts compared to standard control grafts for treating acute deep-partial or full-thickness burn wounds. It employs a prospective, randomized, within-subject controlled design, where participants will receive both types of grafts on adjacent burn sites. The study is divided into two parts: the first part assesses the time to wound bed preparedness over six weeks, while the second part focuses on long-term healing outcomes and scar formation. Participants must have burn injuries that meet specific criteria and will be treated in an outpatient or observational setting.

Who should consider this trial

Good fit: Ideal candidates are adults aged 21 and older with deep partial or full-thickness burn injuries from flame, scald, or contact sources.

Not a fit: Patients with facial burns or those with infections at the time of admission will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly enhance wound healing and improve long-term outcomes for patients with severe burn injuries.

How similar studies have performed: While this approach is innovative, similar studies have not been widely reported, indicating that this may be a novel investigation.

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

Where this trial is running

Augusta, Georgia

• Joseph M Still Research Foundation — Augusta, Georgia, United States (Recruiting)

Study contacts

• Principal investigator: Claus Brandigi, MD — Joseph M Still Research Foundation
• Study coordinator: Joan Wilson

Conditions Burns; Wound Heal