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BurnsSkinBiologicalPhase 4

What this study is

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.

What's being tested

  • Split thickness skin graft

    Intervention · BIOLOGICAL

    standard of care graft

  • microsurfaced split thickness skin graft

    Intervention · BIOLOGICAL

    standard of care graft that has been microsurfaced

Study details

Official title
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
Sponsor
CellTherX
Conditions
Burns · Wound Heal
Enrolling
20 people
Starts
2021-01-04
Est. completion
2021-12
Design
Single-blind, randomized, parallel groups, Phase 4
Record
View on ClinicalTrials.gov ↗