An interventional study of Control Intervention (Conventional Autograft) and Investigational Intervention (RECELL + more widely meshed autograft) in Full-thickness Skin Defects, Degloving Injuries and Crush Injuries, sponsored by Avita Medical. Completed at 18 sites in United States. Open to participants aged 5 Years and older. Per ClinicalTrials.gov, last updated 2024-07-30.
Sponsored by Avita Medical · Not applicable, Interventional, and Treatment
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.
8 studies on the registry are indexed under Crush Injuries; 2 are open to participants now.
Browse Crush Injuries studies →Avita Medical is the lead sponsor of 15 studies on the registry; none are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 5 (56%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
In the opinion of the investigator, the patient and/or guardian must be able to:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Each participant will serve as their own Control, receiving both Control and Investigational Interventions randomly allocated to treatment of a portion of a full-thickness skin defect.
Procedure: Control Intervention (Conventional Autograft) · Device: Investigational Intervention (RECELL + more widely meshed autograft)
Meshed split-thickness skin graft, with standardized wound dressings (Telfa™ Clear and Xeroform™)
Also known as: meshed split-thickness skin graft
More widely meshed split-thickness skin graft, Spray-on Skin™ Cells prepared using RECELL, and standardized wound dressings (Telfa™ Clear and Xeroform™)
Incidence of Treatment Area Healing
The incidence of healing is hypothesized to be non-inferior for RECELL-treated areas (Investigational Intervention) as compared to Control areas (Control Intervention). Healing is defined as complete wound closure characterized by 100% skin re-epithelialization without drainage, confirmed at two consecutive study visits at least 2 weeks apart by direct visualization by a Blinded Evaluator.
Time frame: Prior to or at 8 weeks
Donor Skin Area to Treatment Area Expansion Ratio
The donor skin expansion achieved with treatment using RECELL and widely meshed autograft (Investigational Intervention) is hypothesized to be superior to the donor skin expansion ratio achieved with conventional autograft treatment (Control Intervention). Expansion ratio, computed as the ratio of measured treated area to the measured donor site area, is calculated separately for each Intervention (including any donor skin needed for repeat treatments).
Time frame: Treatment Day
| Milestone | Control Intervention | Investigational Intervention (RECELL) |
|---|---|---|
| Started | 65 | 65 |
| Completed | 47 | 47 |
| Not completed | 18 | 18 |
| Withdrew: Death | 6 | 6 |
| Withdrew: Lost to follow-up | 7 | 7 |
| Withdrew: Withdrawal by subject | 3 | 3 |
| Withdrew: Non-compliance with study schedule | 2 | 2 |
The incidence of healing is hypothesized to be non-inferior for RECELL-treated areas (Investigational Intervention) as compared to Control areas (Control Intervention). Healing is defined as complete wound closure characterized by 100% skin re-epithelialization without drainage, confirmed at two consecutive study visits at least 2 weeks apart by direct visualization by a Blinded Evaluator.
| Treatment Areas | Control Intervention | Investigational Intervention (RECELL) |
|---|---|---|
| Incidence of Treatment Area Healing | 30 | 34 |
The donor skin expansion achieved with treatment using RECELL and widely meshed autograft (Investigational Intervention) is hypothesized to be superior to the donor skin expansion ratio achieved with conventional autograft treatment (Control Intervention). Expansion ratio, computed as the ratio of measured treated area to the measured donor site area, is calculated separately for each Intervention (including any donor skin needed for repeat treatments).
| Expansion Ratio | Control Intervention | Investigational Intervention (RECELL) |
|---|---|---|
| Donor Skin Area to Treatment Area Expansion Ratio | 1.39 ± 0.44 | 1.86 ± 0.47 |
Collected over 26 Weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control Intervention | 6/65 (9.2%) | 2/65 (3.1%) | 35/65 (53.8%) |
| Investigational Intervention (RECELL) | 6/65 (9.2%) | 2/65 (3.1%) | 33/65 (50.8%) |
| Event | Control Intervention | Investigational Intervention (RECELL) |
|---|---|---|
| Impaired HealingGeneral disorders | 2/65 | 2/65 |
| Local Soft Tissue InfectionInfections and infestations | 2/65 | 2/65 |
| Other InfectionInfections and infestations | 2/65 | 2/65 |
| Graft LossInjury, poisoning and procedural complications | 1/65 | 1/65 |
| Skin Graft FailureInjury, poisoning and procedural complications | 1/65 | 1/65 |
| Suture Related ComplicationInjury, poisoning and procedural complications | 0/65 | 1/65 |
| Device MalfunctionProduct Issues | 1/65 | 1/65 |
| Event | Control Intervention | Investigational Intervention (RECELL) |
|---|---|---|
| Impaired HealingGeneral disorders | 14/65 | 12/65 |
| Excessive Granulation TissueSkin and subcutaneous tissue disorders | 8/65 | 12/65 |
| Graft LossInjury, poisoning and procedural complications | 8/65 | 6/65 |
| Wound DecompositionInjury, poisoning and procedural complications | 6/65 | 4/65 |
| Skin ExfoliationSkin and subcutaneous tissue disorders | 4/65 | 5/65 |
| Local Soft Tissue InfectionInfections and infestations | 3/65 | 4/65 |
| PruritusSkin and subcutaneous tissue disorders | 3/65 | 3/65 |
| RashSkin and subcutaneous tissue disorders | 1/65 | 2/65 |
| FallInjury, poisoning and procedural complications | 1/65 | 1/65 |
| Skin Graft FailureInjury, poisoning and procedural complications | 1/65 | 0/65 |
Experimental: All Participants (within patient control)
| Age, Continuous(years) | Experimental: All Participants (Within Patient Control) |
|---|---|
| Mean | 45.7 ± 18.3 |
| Sex: Female, Male(Participants) | Experimental: All Participants (Within Patient Control) |
|---|---|
| Female | 21 |
| Male | 44 |
| Ethnicity (NIH/OMB)(Participants) | Experimental: All Participants (Within Patient Control) |
|---|---|
| Hispanic or Latino | 17 |
| Not Hispanic or Latino | 47 |
| Unknown or Not Reported | 1 |
| Race (NIH/OMB)(Participants) | Experimental: All Participants (Within Patient Control) |
|---|---|
| American Indian or Alaska Native | 2 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 14 |
| White | 46 |
| More than one race | 0 |
| Unknown or Not Reported | 3 |
PDFs hosted by the registry, ClinicalTrials.gov.
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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