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
CellTherX
20 participants
Jan 4, 2021
INTERVENTIONAL
Conditions
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
Inclusion Criteria8
- 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
- years of age or older
Exclusion Criteria9
- 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
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Interventions
standard of care graft
standard of care graft that has been microsurfaced
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT04589442