A Feasibility Study of the ReCell® Autologous Cell Harvesting Device for Healing of Dermabraded Scars

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by Avita Medical
Sponsor:
Information provided by (Responsible Party):
Avita Medical
ClinicalTrials.gov Identifier:
NCT01476826
First received: November 18, 2011
Last updated: October 17, 2012
Last verified: October 2012
  Purpose

This is a prospective, multi-center randomized, evaluator and patient blinded, within-patient controlled feasibility study to evaluate safety and tolerability, and preliminary effectiveness of the ReCell device for healing of the acute wound associated with a dermabraded split thickness meshed graft (STMG) scars The ReCell device is used to prepare a suspension of epidermal and dermal cells from a small sample of a patient's own skin. One of the purposes of this investigation is to learn whether application of the ReCell cell suspension to a wound results in faster healing compared with the standard of care control treatment and longer-term to evaluate scarring of the treated wound sites.

The investigators aim to enroll patients whose STMG scars are large enough and positioned in such a way that treatment and photography are feasible (e.g. not circumferential) and in such a way as to allow a randomly selected half of the scar to be treated with standard of care treatment; i.e., dermabrasion without ReCell (the study control), while the other half is treated using dermabrasion and application of ReCell. Instead of a single contiguous scar, the patient may have two separate but similar scars in anatomically similar areas (e.g. bilateral extremities), one treated with ReCell and the other as a control. Each treatment area will range from a minimum of 50 cm2 to a maximum of 320 cm2.


Condition Intervention Phase
Meshed Split-Thickness Skin Graft Scar
Device: ReCell
Other: Treatment with dermabrasion
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Feasibility Study of the ReCell® Autologous Cell Harvesting Device for Healing of Dermabraded Scars

Resource links provided by NLM:


Further study details as provided by Avita Medical:

Primary Outcome Measures:
  • Safety - adverse events [ Time Frame: Through 24 weeks ] [ Designated as safety issue: Yes ]
  • Clinical healing evaluation (re-epithelialization) [ Time Frame: Through 12 weeks ] [ Designated as safety issue: Yes ]
  • Clinical scar assessment using the POSAS scale [ Time Frame: 12 and 24 weeks ] [ Designated as safety issue: No ]
  • Pain [ Time Frame: Up to 4 weeks ] [ Designated as safety issue: No ]
  • Subject Satisfaction with Treatments [ Time Frame: 12 and 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: January 2012
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment 1
Dermabrasion with treatment with ReCell
Device: ReCell
Treatment with dermabrasion and ReCell
Control
Dermabrasion without treatment with ReCell
Other: Treatment with dermabrasion
Dermabrasion without the treatment with ReCell

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The patient has pre-existing, meshed STSG scar(s) with observable mesh pattern, which may be divided into two 'non-circumferential' sections (contiguous or non-contiguous) feasible to photograph
  2. One scar area between 100 cm2 and 640 cm2 (contiguous) or two 'non-circumferential' sections of similar size approximately (±10%) in anatomically similar areas (e.g. bilateral extremities) between 50 cm2 and 320 cm2 (non-contiguous)
  3. The scar is sufficiently mature for the investigator to determine that the mesh pattern will be persistent over time and dermabrasion is clinically indicated, approximately 6 months old or more
  4. The patient 18 years of age or older
  5. The patient is willing to complete all follow-up evaluations required by the study protocol
  6. The patient is able to abstain from any treatment of the scar other than as directed by the surgeon-investigator for the duration of the study, unless medically necessary
  7. The patient agrees to abstain from enrollment in any other clinical trial for the duration of the study
  8. The patient is able to read and understand instructions and give informed consent
  9. The patient is able and willing to follow the protocol requirement
  10. The patient is able to provide voluntary written informed consent

Exclusion Criteria:

  1. Pregnant/lactating females
  2. The patient has a microbiologically proven pre-existing local or systemic bacterial infection
  3. The patient has been receiving a systemic antibiotic for more than 48 hours prior to treatment of their scar.
  4. The patient has had a prior surgical treatment of the scar.
  5. The patient has history of keloid formation or based on clinical assessment is determined by the investigator to have potential for keloid formation.
  6. The patient is known to have a pre-existing condition that may interfere with wound healing, e.g. malignancy, diabetes or autoimmune disease, immunocompromised blood borne diseases, the patient has AIDS, is HIV- or Hepatitis-C positive, or currently has a severe dermatological disorder (e.g. severe psoriasis, epidermolysis bullosa, pyoderma gangrenosum) or has a WBC < 4000 /μL or > 12,000/μL .
  7. The patient has a documented active bleeding disorder or a clinically significant coagulopathy defined as a PTT>35s or INR>1.4 or platelet count less than 100,000 per mm³.
  8. The patient has a creatinine > 2.0 mg/dL or total bilirubin > 2.5 mg/dL.
  9. The patient is unable to follow the protocol.
  10. The patient is taking medication know to have an effect on wound healing or skin pigmentation (e.g., corticosteroids, retinoids, etc.).
  11. The patient has other concurrent conditions that in the opinion of the investigator may compromise patient safety or study objectives.
  12. The patient has a known hypersensitivity to Trypsin or Compound Sodium Lactate for Irrigation (Hartmann's) solution.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01476826

Contacts
Contact: Andrew Quick 818-356-9400 aquick@avitamedical.com
Contact: Drina Aldana 818-356-9400 daldana@avitamedical.com

Locations
United States, Indiana
Indiana University - Richard M. Fairbanks Burn Center at Wishard Memorial Hospital Recruiting
Indianapolis, Indiana, United States, 46202
Contact: David Roggy    317-630-6399    david.roggy@wishard.edu   
Principal Investigator: Rajiv Sood, MD         
United States, North Carolina
Wake Forest University Health Sciences Withdrawn
Winston-Salem, North Carolina, United States, 27157
United States, Pennsylvania
Lehigh Valley Hospital Recruiting
Allentown, Pennsylvania, United States, 18103
Contact: Lauren Hoover, R.N.    610-402-1735    Lauren_K.Hoover@lvhn.org   
Principal Investigator: Sigrid Blome-Eberwein, M.D.         
Sponsors and Collaborators
Avita Medical
Investigators
Principal Investigator: Rajiv Sood, MD Indiana University Fairbanks Burn Center
  More Information

No publications provided

Responsible Party: Avita Medical
ClinicalTrials.gov Identifier: NCT01476826     History of Changes
Other Study ID Numbers: CTP002-1
Study First Received: November 18, 2011
Last Updated: October 17, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Avita Medical:
Dermabraded wounds

Additional relevant MeSH terms:
Cicatrix
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on July 20, 2014