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RECELL® System Combined With Meshed Autograft for Reduction of Donor Skin Harvesting in Soft Tissue Reconstruction

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ClinicalTrials.gov Identifier: NCT04091672
Recruitment Status : Not yet recruiting
First Posted : September 17, 2019
Last Update Posted : September 17, 2019
Sponsor:
Information provided by (Responsible Party):
Avita Medical

Brief 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.

Condition or disease Intervention/treatment Phase
Full-thickness Skin Defects Degloving Injuries Crush Injuries Laceration of Skin Surgical Wound Skin Cancer Cellulitis Infection Necrotizing Fasciitis Gun Shot Wound Device: Autografting with RECELL overspray Procedure: Conventional Autografting Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 65 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: The participant and blinded evaluator will be not be told which treatment area received which treatment (RECELL or Control).
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : December 2019
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : February 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: All Participants (within patient control)
All subjects will receive both RECELL and skin graft. Each patient serves as their own control. Their study treatment area will be divided into Area A and Area B. Investigational treatment (RECELL) will be randomly allocated to either Area A or Area B
Device: Autografting with RECELL overspray
Autografting more widely meshed than the pre-specified grafting plan with RECELL overspray, along with Telfa™ Clear and Xeroform™ wound dressings

Procedure: Conventional Autografting
Autografting according to the pre-specified grafting plan, along with Telfa™ Clear and Xeroform™ wound dressings




Primary Outcome Measures :
  1. Confirmed Healing [ Time Frame: Prior to or at 8 weeks ]
    Healing is defined as ≥95% skin re-epithelialization without drainage, confirmed at two consecutive study visits at least 2 weeks apart by direct visualization by a Blinded Evaluator. The incidence of healing is hypothesized to be non-inferior for RECELL-treated areas as compared to Control areas.

  2. Actual Expansion Ratios [ Time Frame: Prior to or at 8 weeks ]
    Actual expansion ratio, computed as the ratio of measured treated area to the measured donor site area, will be calculated separately for RECELL and Control (including donor skin needed for secondary treatments). The actual expansion ratios will be compared as a new ratio (ratio of ratios). The actual expansion ratio achieved with the use of RECELL is hypothesized to be superior to the actual expansion ratio associated with the Control.


Other Outcome Measures:
  1. POSAS (Patient and Observer Scar Assessment Scale) [ Time Frame: At weeks 26, 36 and 52 ]
    Blinded evaluator and subject overall opinion score (1-10), where 10 corresponds to the worst imaginable scar

  2. Subject Treatment Preference [ Time Frame: At week 52 ]
    Subjects will be asked to specify which treatment region they are more satisfied with (A or B)



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Ages Eligible for Study:   5 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The patient requires autografting for treatment of an acute full-thickness skin defect (e.g., trauma- or surgery-related).
  2. The maximum area requiring autografting is 50% Total Body Surface Area (TBSA).
  3. Two comparable areas requiring autografting, each at least 160 cm2 (or 320 cm2 contiguous), excluding face and genitalia. When hands or joints are included in the treatment areas, comparability of treatment areas means that each area (RECELL and Control) must include the same contralateral joint and/or hand.
  4. The patient is at least 5 years of age.
  5. The patient (or parent/guardian) is willing and able to comply with all compulsory study procedures and visit schedule.
  6. The patient agrees to abstain from any other treatment (e.g., external fixation) of the study treatment areas for the duration of his/her participation the study (1 year).
  7. The patient agrees to abstain from enrollment in any other interventional clinical trial for the duration of his/her participation the study (1 year).
  8. In the opinion of the investigator, the patient and/or guardian must be able to:

    1. Understand the full nature and purpose of the study, including possible risks and adverse events,
    2. Understand instructions, and
    3. Provide voluntary informed written consent.

Exclusion Criteria:

  1. Not able to understand English or Spanish.
  2. The area requiring autografting sustained a burn injury.
  3. The treatment area has previously failed to heal subsequent to surgical intervention for closure.
  4. The patient is unable to follow the protocol requirements.
  5. The patient has a condition that in the investigator's opinion may compromise patient safety or trial objectives.
  6. Current use of medications that in the investigator's opinion may compromise patient safety or trial objectives.
  7. The patient has a known hypersensitivity to trypsin or compound sodium lactate for irrigation (Hartmann's) solution.
  8. Life expectancy is less than 1 year.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04091672


Contacts
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Contact: Elizabeth Kirshner 661-367-9170 ekirshner@avitamedical.com

Sponsors and Collaborators
Avita Medical

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Responsible Party: Avita Medical
ClinicalTrials.gov Identifier: NCT04091672     History of Changes
Other Study ID Numbers: CTP007
First Posted: September 17, 2019    Key Record Dates
Last Update Posted: September 17, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Additional relevant MeSH terms:
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Cellulitis
Fasciitis, Necrotizing
Fasciitis
Surgical Wound
Lacerations
Crush Injuries
Wounds, Gunshot
Degloving Injuries
Wounds and Injuries
Musculoskeletal Diseases
Skin Diseases, Infectious
Infection
Suppuration
Connective Tissue Diseases
Inflammation
Pathologic Processes
Skin Diseases, Bacterial
Bacterial Infections
Wounds, Penetrating
Soft Tissue Injuries