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RECELL® System Combined With Meshed Autograft for Reduction of Donor Skin Harvesting in Soft Tissue Reconstruction

NCT04091672 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2024-07-30

Study results available
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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.

Conditions

  • Full-thickness Skin Defects
  • Degloving Injuries
  • Crush Injuries
  • Laceration of Skin
  • Surgical Wound
  • Skin Cancer
  • Cellulitis
  • Infection
  • Necrotizing Fasciitis
  • Gun Shot Wound

Interventions

PROCEDURE

Control Intervention (Conventional Autograft)

Meshed split-thickness skin graft, with standardized wound dressings (Telfa™ Clear and Xeroform™)

DEVICE

Investigational Intervention (RECELL + more widely meshed autograft)

More widely meshed split-thickness skin graft, Spray-on Skin™ Cells prepared using RECELL, and standardized wound dressings (Telfa™ Clear and Xeroform™)

Sponsors & Collaborators

  • Avita Medical

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-02
Primary Completion
2022-03-07
Completion
2023-02-02
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT04091672 on ClinicalTrials.gov