Clinical Evidence | RECELL® System

Clinical Evidence

Clinically Proven for Definitive Closure and Favorable Donor Site Outcomes

A robust body of clinical evidence, including two multi-center, randomized, controlled clinical trials and more than 50 peer-reviewed publications, demonstrates that RECELL® is designed to achieve favorable outcomes. Among the benefits versus standard of care are: reduced donor skin requirements,1 earlier and superior donor site healing,2 less pain and scarring at the donor site,2 reduced length of hospital stay for small deep partial-thickness and full-thickness burns,3,4,5 and fewer surgical procedures for definitive closure.1,3,6
Below are the results of two multi-center, randomized, controlled clinical trials of 131 total patients with deep partial-thickness to full-thickness burns.2,7

Significantly less donor skin required1

RECELL®: Donor Skin Requirement

Earlier and superior donor site healing vs STSG donor site2

Healing 1 week after treatment
Healing 2 weeks after treatment

Reduce pain and scarring at the donor site with RECELL vs SOC at all time points2

Donor Site Patient-Reported Pain VAS Ratings
Donor Site Physician-Reported VVS Ratings

Comparable incidence of definitive wound closure in mixed-depth burns (inclusive of FT) with RECELL vs control7

Comparable Incidence of Definitive Wound Closure in Mixed-depth Burns (Inclusive of FT) With Recell Vs. Control

Fewer autografting procedures required for definitive closure vs conventional autograft1,3,6

Fewer Autografting Procedures Required for Definitive Closure Vs Conventional Autograft
  1. RECELL Autologous Cell Harvesting Device. Instructions for Use for AVRL0101.
  2. Holmes JH, Molnar JA, Carter JE, et al. A comparative study of the RECELL® device and autologous split-thickness meshed skin graft in the treatment of acute burn injuries. J Burn Care Res. 2018;39(5):694-7023.
  3. Kowal S et al. Adv Ther. 2019;36(7):1715-1729.
  4. Park JH et al. Burns. 2013;39(7):1386-1390.
  5. Carter JE et al. J Burn Care Res. 2020;41(S1):S37-S38.
  6. Foster K, Bilir P, Kruger E, et al. Cost-effectiveness of RECELL® Autologous Cell Harvesting Device (ACHD) versus STSG for treatment of severe burns in the United States. Presented at the American Burn Association 2018 Annual Meeting, April 2018.
  7. Holmes JH, Molnar JA, Shupp JW, et al. Demonstration of the safety and effectiveness of the RECELL® system combined with split-thickness meshed autografts for the reduction of donor skin to treat mixed-depth burn injuries. Burns. 2019;45(4):772-782.