Microsurfaced Grafts in Deep Burn Wounds
Purpose
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.
Conditions
- Burns
- Wound Heal
Eligibility
- Eligible Ages
- Over 21 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 4
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator Standard of Care Dermal Graft |
Standard of care cryopreserved cadaveric split thickness skin grafts |
|
|
Experimental Standard of Care Dermal Graft - Microsurfaced |
Microsurfaced cryopreserved cadaveric split thickness skin grafts |
|
Recruiting Locations
Joseph M Still Research Foundation
Augusta, Georgia 30909
Augusta, Georgia 30909
More Details
- NCT ID
- NCT04589442
- Status
- Recruiting
- Sponsor
- CellTherX