Microsurfaced Grafts in Deep Burn Wounds

Launched by CELLTHERX · Oct 9, 2020

Keywords

ClinConnect Summary

This clinical trial is studying how effective two types of skin grafts—microsurfaced and control cadaveric grafts—are for treating deep burn wounds. The goal is to see which graft helps wounds heal better and faster. Participants will have both types of grafts applied to their burn wounds, allowing researchers to compare the healing process. The trial is divided into two parts: the first part looks at how quickly the wound is ready for healing over six weeks, and the second part examines the overall healing, how well the grafts take, and the long-term appearance of scars.

To be eligible for this study, participants must be at least 21 years old and have suffered a deep partial or full thickness burn from flame, scald, or contact injuries. The burn site should be large enough to accommodate both types of grafts, and the total area burned must be less than 30% of the body. Participants will need to sign a consent form and must not have infections or be pregnant. Those who join can expect close monitoring and care, as the study aims to improve outcomes for burn victims.

Gender

ALL

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