An observational study in Burns, sponsored by Avita Medical. Completed at 6 sites in United States. Open to participants aged 5 Years and older. Per ClinicalTrials.gov, last updated 2024-07-30.
Sponsored by Avita Medical · Observational
The overall purpose of this continued access study is to allow ongoing treatment of subjects at selected investigational sites while the marketing application for the ReCell® Autologous Cell Harvesting Device is under FDA review. This is a prospective, multicenter, single-arm observational study to evaluate the safety and clinical performance of the ReCell® device when used as an adjunct to meshed autografts in patients with acute thermal burn injuries requiring skin grafting for closure.
Patients 5 years or older with a total body surface area (TBSA) thermal burn injury between 5 and 50% (inclusive) who require autografting will be considered for participation in this study. RES (Regenerative Epithelial Suspension) derived from the use of the ReCell® device will be applied over skin grafts meshed more widely than conventional autografting. Healing, scar outcomes, pain and treatment-related adverse events will be evaluated at follow-up visits. Data concerning the clinical performance and safety of the ReCell device will be collected. Safety will be evaluated in terms of treatment and serious related adverse events.
Each subject will participate in up to 7 total visits (treatment visit and 6 follow-up study visits) over a period of 24 weeks. Up to 60 subjects will be enrolled and treated within this study at up to 15 institutions.
It is anticipated that enrollment will continue until PMA approval. Subject follow-up will continue until the last enrolled subject completes the 24-week visit.
905 studies on the registry are indexed under Burns; 164 are open to participants now.
This study's enrollment of 76 is above the median of 64 across 163 observational studies indexed under Burns.
Browse Burns 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.
Burn Unit
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.
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.
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.
Device: ReCell® Autologous Cell Harvesting Device
RES (Regenerative Epithelial Suspension) derived from the use of the ReCell® device will be applied over skin grafts meshed more widely than conventional autografting.
Percentage of Participants With Wound Healing
Treatment area will be evaluated via direct visualization by the treating investigator. Complete wound closure is defined as ≥95 to100% re-epithelialization without drainage by week 8.
Time frame: Confirmed by week 8, at two consecutive study visits at least 2 weeks apart up to 24 Weeks (e.g., at week 4 and week 8, or if a visit was missed, week 4 and week 12)
| Milestone | RES (Regenerative Epithelial Suspension) |
|---|---|
| Started | 76 |
| Completed | 63 |
| Not completed | 13 |
| Withdrew: Lost to follow-up | 10 |
| Withdrew: Death | 2 |
| Withdrew: Adverse event | 1 |
Treatment area will be evaluated via direct visualization by the treating investigator. Complete wound closure is defined as ≥95 to100% re-epithelialization without drainage by week 8.
| percentage of participants | RES (Regenerative Epithelial Suspension) |
|---|---|
| Percentage of Participants With Wound Healing | 95.3 |
Collected over 24 Weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| RES (Regenerative Epithelial Suspension) | 3/76 (3.9%) | 16/76 (21.1%) | 39/76 (51.3%) |
| Event | RES (Regenerative Epithelial Suspension) |
|---|---|
| Non-healing Third Degree Burn R/T Caffeine Intake Capillary Constriction LL Arm Req. Add'l GraftingInjury, poisoning and procedural complications | 1/76 |
| Pseudomonas Infection of GraftsInfections and infestations | 1/76 |
| Graft Loss Due to Immobility Over Posteriorly Located Pressure Bearing Surfaces Requiring Re-graftinInjury, poisoning and procedural complications | 1/76 |
| Wound Cultures Positive for Staph Aureus Requiring Surgical InterventionInfections and infestations | 1/76 |
| Area of Flap Dehisced Requiring Inset of Flap Under AnesthesiaInjury, poisoning and procedural complications | 1/76 |
| Inpatient Surgery for Excision and Scar ReleaseInjury, poisoning and procedural complications | 1/76 |
| Graft Loss with Wound InfectionInfections and infestations | 1/76 |
| Wound Infection Pseudomonas AeruginosaInfections and infestations | 1/76 |
| Graft Failure with Wound InfectionInfections and infestations | 1/76 |
| 100% Graft Loss Right LegInjury, poisoning and procedural complications | 1/76 |
| Event | RES (Regenerative Epithelial Suspension) |
|---|---|
| Burn Site PainGeneral disorders | 7/76 |
| Burn Site PainGeneral disorders | 4/76 |
| NauseaGastrointestinal disorders | 3/76 |
| ItchingSkin and subcutaneous tissue disorders | 2/76 |
| Burn ItchingSkin and subcutaneous tissue disorders | 2/76 |
| EpistaxisRespiratory, thoracic and mediastinal disorders | 2/76 |
| FeverGeneral disorders | 2/76 |
| Ulnar Neuropathy of Left Upper ExtremityVascular disorders | 1/76 |
| Worsening of Previous Medical History of Neuropathic PainVascular disorders | 1/76 |
| Increase in Past Medical History of Acute Pain due to Burn InjuryInjury, poisoning and procedural complications | 1/76 |
| Age, Categorical(Participants) | RES (Regenerative Epithelial Suspension) |
|---|---|
| <=18 years | 10 |
| Between 18 and 65 years | 54 |
| >=65 years | 12 |
| Age, Continuous(years) | RES (Regenerative Epithelial Suspension) |
|---|---|
| Mean | 43.8 ± 20.45 |
| Sex: Female, Male(Participants) | RES (Regenerative Epithelial Suspension) |
|---|---|
| Female | 25 |
| Male | 51 |
| Race (NIH/OMB)(Participants) | RES (Regenerative Epithelial Suspension) |
|---|---|
| American Indian or Alaska Native | 2 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 20 |
| White | 49 |
| More than one race | 0 |
| Unknown or Not Reported | 5 |
| Region of Enrollment(participants) | RES (Regenerative Epithelial Suspension) |
|---|---|
| United States | 76 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
Ran from Oct 2017 to primary completion in Dec 2018, 13 months.
Results were first posted in Jul 2021, 2 years 7 months after primary completion.
Of 68 observational studies under Burns, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 56. This study's 13 months is below that.
How these figures are worked out, and which studies are left out of them.
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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