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

• 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 ]

• Assessment of treatment-related adverse events, unexpected and expected serious 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 ]

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.

• Device: ReCell
  Treatment with dermabrasion and ReCell
• Other: Treatment with dermabrasion
  Dermabrasion without the treatment with ReCell

• Experimental: Treatment 1
  Dermabrasion with treatment with ReCell
  Intervention: Device: ReCell
• Control
  Dermabrasion without treatment with ReCell
  Intervention: Other: Treatment with dermabrasion

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.