N/A
N=101
A Multicenter Comparative Study of the ReCell Device and Autologous Split-thickness Meshed Skin Graft in the Treatment of Acute Burn Injuries
Burns
Bottom Line
View on ClinicalTrials.gov: NCT01138917 ↗Enrolled (actual)
101
Serious AEs
9.9%
Results posted
May 2019
Primary outcome: Primary: Incidence of RECELL-treated Area Closure Compared to Control at 4 Weeks (Non-inferiority) — 82; 87; 82; 83 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- ReCell and Split-thickness skin graft (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Avita Medical
- Primary completion
- Aug 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of RECELL-treated Area Closure Compared to Control at 4 Weeks (Non-inferiority) |
82; 87; 82; 83; 84; 97 | — |
| PRIMARY Incidence of RECELL Donor Site Healing Compared to Control at 1 Week (Superiority) |
22; 10; 19; 10; 18; 10 | — |
| SECONDARY Percent of Epithelialization at Each Visit Through Week 16 |
66.1; 74.0; 92.1; 99.8; 95.8; 99.9 | — |
| SECONDARY Wound Closure at Week 2 (Based on Investigators Assessment) |
70; 1; 16; 0 | — |
| SECONDARY Mean Pain and Appearance Scores at RECELL and Control Recipient Sites (Subject Assessment) |
24.1; 26.5; 12.4; 12.4; 9.6; 7.9 | — |
| SECONDARY Mean Pain and Appearance Scores at Donor Sites (Subject Assessment) |
21.9; 43.5; 5.1; 19.3; 1.9; 9.4 | — |
Summary
This is a randomized, within-patient controlled study to compare the clinical performance of the ReCell Device with that of Split-thickness Meshed Skin Grafts for the treatment of second degree burns. The hypothesis to be supported are: 1) non-inferiority with the primary efficacy endpoint defined as recipient site wound closure at week 4 follow-up visit of the ReCell-treated area as compared to that of the STMSG-treated area, and 2)superiority in the healing of the ReCell donor site as compared to the STMSG donor site at week 1.
Eligibility Criteria
Inclusion Criteria
- The subject requires primary skin grafting as a result of an acute thermal burn injury
- The area of the burn injury is at least 200cm2 (1% TBSA in adults) if a contiguous wound, or at least 100cm2 for each of 2 noon-contiguous wounds
- The area of total burn injury is 1-20% TBSA
- The burn injured area can be divided into two treatment areas ( control and treatment) with 100-320cm2 area for each treatment type
- The study treatment area is a second degree burn injury
- The subject is between 18-65 years of age
- The subject is willing to complete all follow-up evaluations required by the study protocol
- The subject is to abstain from any other treatment of the wound(s) for the duration of the study unless medically necessary
- The subject agrees to abstain from enrollment in any other clinical trial for the duration of the study
- The subject and/or guardian are able to read and understand instructions and give informed, voluntary, written consent
- The subject is able and willing to follow the protocol requirements
Exclusion Criteria
- The subject's burn injuries were caused by chemicals, electricity, and/or radioactive substances
- The total subject burn injury is less than 1% or more than 20% TBSA
- The subject has a microbiologically proven pre-existing local or systemic bacterial infection
- The subject has been receiving a systemic antibiotic for more than 48 hours prior to grafting
- The subject is known to have a pre-existing condition that may interfere with wound healing ( e.g. malignancy, diabetes, or autoimmune disease)
- The subject is unable to follow the protocol
- The subject is taking medication known to have an effect on wound healing or skin pigmentation ( e.g. systemic corticosteroids, retinoids, etc)
- The subject has other concurrent conditions that in the opinion of the investigator may compromise patient safety or study objectives
- The subject has a known hypersensitivity to Trypsin or Compound sodium Lactate for Irrigation (Hartmann's) solution
Data sourced from ClinicalTrials.gov (NCT01138917). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.