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

CellTherX1 site in 1 country20 target enrollmentJanuary 4, 2021

ConditionsBurns Wound Heal

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Burns
Sponsor: CellTherX
Enrollment: 20
Locations: 1
Primary Endpoint: Wound bed prep
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

January 4, 2021

End Date

December 2021

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

CellTherX

Responsible Party

Sponsor

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 cm
•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

Outcomes

Primary Outcomes

Wound bed prep

Time Frame: 6 week

To compare wound bed preparedness/time to autograft in deep-partial and full thickness burns and burn wound healing in partial thickness burns in burn sites treated with Microsurfaced vs Control cadaveric graft-treated groups through 6 weeks post initial injury.