Microsurfaced Grafts in Deep Burn Wounds

Phase 4

• Conditions: Burns; Wound Heal

• Registration Number: NCT04589442
• Lead Sponsor: CellTherX

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-05
• Study First Submitted QC: 2020-10-09
• Study First Posted: 2020-10-19
• Status Verified: 2021-01
• Study Start: 2021-01-04
• Last Update Submitted: 2021-01-13
• Last Update Posted: 2021-01-15
• Primary Completion: 2021-08
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Wound bed prep	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.

Secondary Outcome Measures

Name	Time	Method
Tissue oxygenation	3, 6, 9, 12 months	Tissue oxygenation will be assessed using hyperspectral imaging
Infection	Through 12 months	Incidence of Infection at each treatment study visit
Autograft take	2 weeks	Autograft take will be documented as a percentage of the graft by the physician
Tissue Oxygenation	6 weeks	Change in tissue oxygenation at study burn site at the time of autografting as compared to baseline.
Scar assessment	3, 6, 9, 12 months	Scar will be assessed using the Patient and Observer Scar Assessment Scale (POSAS)

Trial Locations

Locations (1)

Joseph M Still Research Foundation; 🇺🇸 Augusta, Georgia, United States