Trials / Recruiting
RecruitingNCT04589442
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
- Status
- Recruiting
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- Sponsor
- CellTherX · Industry
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Split thickness skin graft | standard of care graft |
| BIOLOGICAL | microsurfaced split thickness skin graft | standard of care graft that has been microsurfaced |
Timeline
- Start date
- 2021-01-04
- Primary completion
- 2021-08-01
- Completion
- 2021-12-01
- First posted
- 2020-10-19
- Last updated
- 2021-01-15
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04589442. Inclusion in this directory is not an endorsement.