Summary

Eligibility
for people ages 5 years and up (full criteria)
Location
at Orange, California and other locations
Dates
study started
estimated completion

Description

Summary

A prospective randomized within-subject controlled study to compare the clinical performance of conventional autografting with and without the RECELL system on acute non-burn full-thickness skin defects.

Official Title

A Prospective Multicenter Randomized Controlled Clinical Study to Investigate the Safety and Effectiveness of the RECELL® System Combined With Meshed Autograft for Reduction of Donor Skin Harvesting in Soft Tissue Reconstruction

Keywords

Full-thickness Skin Defects Degloving Injuries Crush Injuries Laceration of Skin Surgical Wound Skin Cancer Cellulitis Infection Necrotizing Fasciitis Gun Shot Wound Fasciitis, Necrotizing Fasciitis Wounds and Injuries Lacerations Wounds, Gunshot Autografting with RECELL overspray

Eligibility

You can join if…

Open to people ages 5 years and up

  1. The patient requires autografting for treatment of an acute full-thickness skin defect (e.g., trauma- or surgery-related).
  2. The maximum area requiring autografting is 50% Total Body Surface Area (TBSA).
  3. Two comparable areas requiring autografting, each at least 160 cm2 (or 320 cm2 contiguous), excluding face and genitalia. When hands or joints are included in the treatment areas, comparability of treatment areas means that each area (RECELL and Control) must include the same contralateral joint and/or hand.
  4. The patient is at least 5 years of age.
  5. The patient (or parent/guardian) is willing and able to comply with all compulsory study procedures and visit schedule.
  6. The patient agrees to abstain from any other treatment (e.g., external fixation) of the study treatment areas for the duration of his/her participation the study (1 year).
  7. The patient agrees to abstain from enrollment in any other interventional clinical trial for the duration of his/her participation the study (1 year).
  8. In the opinion of the investigator, the patient and/or guardian must be able to:
  9. Understand the full nature and purpose of the study, including possible risks and adverse events,
  10. Understand instructions, and
  11. Provide voluntary informed written consent.

You CAN'T join if...

  1. Not able to understand English or Spanish.
  2. The area requiring autografting sustained a burn injury.
  3. The treatment area has previously failed to heal subsequent to surgical intervention for closure.
  4. The patient is unable to follow the protocol requirements.
  5. The patient has a condition that in the investigator's opinion may compromise patient safety or trial objectives.
  6. Current use of medications that in the investigator's opinion may compromise patient safety or trial objectives.
  7. The patient has a known hypersensitivity to trypsin or compound sodium lactate for irrigation (Hartmann's) solution.
  8. The patient is pregnant or breast-feeding (pregnancy test should be performed in accordance with local institutional requirements).
  9. Life expectancy is less than 1 year.

Locations

  • UCI Medical Center not yet accepting patients
    Orange California 92868 United States
  • Arizona Burn Center - Valleywise Health accepting new patients
    Phoenix Arizona 85008 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Avita Medical
ID
NCT04091672
Study Type
Interventional
Last Updated