deltatrials
Terminated NA INTERVENTIONAL 2-arm NCT03626701

RES® Prepared With RECELL® Compared to Standard of Care Dressings of Partial-thickness Burns in Ages 1-16 Years

A Prospective Multicenter Randomized Controlled Clinical Study to Investigate the Safety and Effectiveness of RES® (Regenerative Epidermal Suspension) Prepared With the RECELL® Device Compared to Standard of Care Dressings for Treatment of Partial-thickness Burns in Infants, Children and Adolescents (Aged 1-16 Years)

Sponsor: Avita Medical

Conditions Burns
Interventions Conventional autografting (only when indicated) Mepilex® Ag Wound Dressing RES (Regenerative Epidermal Suspension) prepared using the RECELL® Autologous Cell Harvesting Device
Updated 15 times since 2018 Last updated: Jul 9, 2024 Started: Mar 3, 2020 Primary completion: Jun 23, 2021 Completion: Jun 3, 2022
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

In June 2021, the US FDA approved expanded use of the RECELL System for treatment of acute full-thickness thermal burns in patients 1-month of age and older (removing the prior limitation of use in patients younger than 18 years of age).

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A NA clinical study on Burns, this trial is terminated or withdrawn. The trial is conducted by Avita Medical and has accumulated 15 data snapshots since 2020. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

~Sep 2018 – ~Feb 2020 · 17 months · monthly snapshot~Feb 2020 – ~Apr 2020 · 2 months · monthly snapshot~Apr 2020 – ~Sep 2020 · 5 months · monthly snapshot~Sep 2020 – ~Jan 2021 · 4 months · monthly snapshot~Jan 2021 – ~Sep 2021 · 8 months · monthly snapshot~Sep 2021 – ~Apr 2022 · 7 months · monthly snapshot~Apr 2022 – ~Jun 2022 · 2 months · monthly snapshot~Jun 2022 – ~Sep 2022 · 3 months · monthly snapshot~Sep 2022 – ~Dec 2022 · 3 months · monthly snapshot~Dec 2022 – ~Jul 2023 · 7 months · monthly snapshot~Jul 2023 – ~Sep 2023 · 2 months · monthly snapshot~Sep 2023 – ~Jul 2024 · 10 months · monthly snapshot~Jul 2024 – ~Aug 2024 · 31 days · monthly snapshot~Aug 2024 – ~Sep 2024 · 31 days · monthly snapshot~Sep 2024 – present · 22 months · monthly snapshot

Change History

15 versions recorded

  1. Sep 2024 — Present [monthly]

    Terminated NA

  2. Aug 2024 — Sep 2024 [monthly]

    Terminated NA

  3. Jul 2024 — Aug 2024 [monthly]

    Terminated NA

  4. Sep 2023 — Jul 2024 [monthly]

    Terminated NA

  5. Jul 2023 — Sep 2023 [monthly]

    Terminated NA

▶ Show 10 earlier versions

  1. Dec 2022 — Jul 2023 [monthly]

    Terminated NA

    Status: Active Not Recruiting → Terminated

  2. Sep 2022 — Dec 2022 [monthly]

    Active Not Recruiting NA

  3. Jun 2022 — Sep 2022 [monthly]

    Active Not Recruiting NA

  4. Apr 2022 — Jun 2022 [monthly]

    Active Not Recruiting NA

  5. Sep 2021 — Apr 2022 [monthly]

    Active Not Recruiting NA

    Status: Recruiting → Active Not Recruiting

  6. Jan 2021 — Sep 2021 [monthly]

    Recruiting NA

  7. Sep 2020 — Jan 2021 [monthly]

    Recruiting NA

  8. Apr 2020 — Sep 2020 [monthly]

    Recruiting NA

    Status: Not Yet Recruiting → Recruiting

  9. Feb 2020 — Apr 2020 [monthly]

    Not Yet Recruiting NA

  10. Sep 2018 — Feb 2020 [monthly]

    Not Yet Recruiting NA

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Avita Medical
  • Biomedical Advanced Research and Development Authority
Data source: Avita Medical

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations