CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 65 enrolled
Drug / intervention
Control Intervention (Conventional Autograft) +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04091672
NCT04091672N/ACompleted
CompareCT.gov

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

Avita Medical·interventional·Posted Sep 17, 2019·Updated Jul 30, 2024

In Brief

A clinical study evaluating Control Intervention (Conventional Autograft) and Investigational Intervention (RECELL + more widely meshed autograft) for Full-thickness Skin Defects and 9 related conditions. Completed, enrolled 65 participants across 18 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFull-thickness Skin Defects, Degloving Injuries, Crush Injuries, Laceration of Skin, Surgical Wound, Skin Cancer, Cellulitis, Infection, Necrotizing Fasciitis, Gun Shot Wound
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedSep 17, 2019
Enrollment StartMar 2, 2020
Primary CompletionMar 7, 2022
Study CompletionFeb 2, 2023
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 6.8 years ago

Interventions

Control Intervention (Conventional Autograft)procedure

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

Investigational Intervention (RECELL + more widely meshed autograft)device

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