Microsurfaced Grafts in Deep Burn Wounds

Part of paid clinical trials in Augusta, Georgia.

Sponsor
CellTherX
Study ID
NCT04589442
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

  • Burns
  • Wound Heal

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Split thickness skin graft — BIOLOGICAL
    standard of care graft
  • microsurfaced split thickness skin graft — BIOLOGICAL
    standard of care graft that has been microsurfaced

Study Details

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.

Key Dates

Start date
Jan 4, 2021
Status verified
Jan 2021
Primary completion
Aug 31, 2021
Completion
Dec 31, 2021

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Standard of Care Dermal Graft
    Standard of care cryopreserved cadaveric split thickness skin grafts
  • Experimental: Standard of Care Dermal Graft - Microsurfaced
    Microsurfaced cryopreserved cadaveric split thickness skin grafts

Primary Outcome Measure

Wound bed prep [ Time Frame: 6 week ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Joseph M Still Research FoundationAugustaGeorgia30909
Joan Wilson
[email protected]
706-364-2966
Claus Brandigi, MD (PRINCIPAL_INVESTIGATOR)

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Joseph M Still Research Foundation· Augusta, GA

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