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Microsurfaced Grafts in 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
Who can join
Ages 21 and older · All sexes
Full 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
About the study
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.
What is being tested
- Split thickness skin graft (biological)
- microsurfaced split thickness skin graft (biological)
Sponsor: CellTherX · Participants: 20 · Started: Jan 4, 2021
Contact the study team
- Joan Wilson · Phone: 706-364-2966
Official record on ClinicalTrials.gov — NCT04589442
Locations in the U.S.
| Georgia | Joseph M Still Research Foundation, Augusta |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.