A Comparative Study of the ReCell® Device and Autologous Split-Thickness Meshed Skin Graft in the Treatment of Acute Burn Injuries

Abstract

Early excision and autografting are standard care for deeper burns. However, donor sites are a source of significant morbidity. To address this, the ReCell® Autologous Cell Harvesting Device (ReCell) was designed for use at the point-of-care to prepare a noncultured, autologous skin cell suspension (ASCS) capable of epidermal regeneration using minimal donor skin. A prospective study was conducted to evaluate the clinical performance of ReCell vs meshed split-thickness skin grafts (STSG, Control) for the treatment of deep partial-thickness burns. Effectiveness measures were assessed to 1 year for both ASCS and Control treatment sites and donor sites, including the incidence of healing, scarring, and pain. At 4 weeks, 98% of the ASCS-treated sites were healed compared with 100% of the Controls. Pain and assessments of scarring at the treatment sites were reported to be similar between groups. Significant differences were observed between ReCell and Control donor sites. The mean ReCell donor area was approximately 40 times smaller than that of the Control (P < .0001), and after 1 week, significantly more ReCell donor sites were healed than Controls (P = .04). Over the first 16 weeks, patients reported significantly less pain at the ReCell donor sites compared with Controls (P ≤ .05 at each time point). Long-term patients reported higher satisfaction with ReCell donor site outcomes compared with the Controls. This study provides evidence that the treatment of deep partial-thickness burns with ASCS results in comparable healing, with significantly reduced donor site size and pain and improved appearance relative to STSG.

Indeterminate-Depth Burn Injury—Exploring the Uncertainty

“…The presence of melanocytes in the cell suspension also had a favorable impact on final pigmentation compared with other systems. 78 When compared with meshed autograft, ReCell had a slightly more favorable final pigmentation, and was similar to unmeshed graft with respect to final pigmentation. 78 Disadvantages of the system include high cost and loss of cells during spraying.…”

“…78 When compared with meshed autograft, ReCell had a slightly more favorable final pigmentation, and was similar to unmeshed graft with respect to final pigmentation. 78 Disadvantages of the system include high cost and loss of cells during spraying. 65 StrataGraft StrataGraft (Stratatech-Mallinkcrodt, Madison, WI) is a stratified bilayer skin substitute that has shown great promise, earning an "orphan product" designation from the FDA in 2012 and "Regenerative Medicine Advanced Therapy" designation in 2017.…”

“…73 In a recent multicenter RCT, the ReCell system was compared with 2:1 meshed STSG for the management of deep partial-thickness burnsddefined as a wound that contained viable dermis throughout the wound base. 77,78 The study found that there was no difference in healing, pain, subject satisfaction, or scarring outcomes at 4 wk. The ReCell system had the advantage of a smaller harvested donor site (2 cm 2 for ReCell versus 110 cm 2 for autograft) with less postoperative pain and improved patient satisfaction due to a smaller donor site.…”

Current and Future Perspectives on Skin Tissue Engineering: Key Features of Biomedical Research, Translational Assessment, and Clinical Application

“…The cell suspension predominantly contains keratinocytes (>64%), but also includes significant populations of fibroblasts and viable melanocytes . Holmes et al completed a comparative clinical study of RECELL and autologous split‐thickness skin grafting in the treatment of acute burns, where the clinical outcomes of the former were as effective as the latter while requiring almost 40 times less donor tissue . Patients in this study reported significantly less pain at the donor sites, perceived greater improvement in wound appearance, and expressed overall higher satisfaction than patients receiving skin grafts.…”

“…The most recently approved burn treatment, RECELL, received approval in September 2018. It began clinical trials in 2010 and has since been used on approximately 250 patients in the US, either as part of the clinical trial protocol or under compassionate use . Clinical trials for regenerative medicine therapies often require a long‐time enroll enough subjects to meet the study requirements or long‐term endpoints to ensure safety.…”