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Microsurfaced Grafts in Deep Burn Wounds

NCT04589442 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2021-01-15

No results posted yet for this study

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

  • Burns
  • Wound Heal

Interventions

BIOLOGICAL

Split thickness skin graft

standard of care graft

BIOLOGICAL

microsurfaced split thickness skin graft

standard of care graft that has been microsurfaced

Sponsors & Collaborators

  • CellTherX

    lead INDUSTRY

Principal Investigators

  • Claus Brandigi, MD · Joseph M Still Research Foundation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-04
Primary Completion
2021-08-31
Completion
2021-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04589442 on ClinicalTrials.gov