Poster: A Comparative Effectiveness Research Study of a Bilayered Living Cellular Construct and Two Skin Grafts for Use in Venous Leg Ulcers

In this study, the authors used real-world data to conduct a comparative-effectiveness analysis in which they evaluated the healing rates of 8487 venous leg ulcers (VLUs) treated with either a bilayered living cellular construct (BLCC [Apligraf, Organogenesis Inc]) or two skin grafts (cryopreserved cadaveric skin allograft; CCSA [TheraSkin, Misonix])/non-cryopreserved human skin autograft (SA) between 2011 and 2020.

VLUs commonly develop along the medial or lateral distal leg and result from a combination of macroscopic and microscopic pathophysiologic processes.¹ At present, there is a BLCC approved by the US Food and Drug Administration for the treatment of VLUs. The BLCC contains living keratinocytes and fibroblasts that produce growth factors and cytokines.

The authors used the following for their study of 8487 VLUs:

• Ulcers need to have been ≥ 28 days duration, with areas ≥ 1cm² and < 20 cm².
• Patients with no baseline wound measurements or follow-up visits were excluded.
• Evaluations were performed on 7,956 BLCC-treated and 531 CCSA/SA-treated VLUs.
• The treatment period started with the first use of BLCC or CCSA/SA.

The study patient populations were comparable for patient demographics, wound characteristics, and treatment characteristics. The authors reported a median time to heal at 99 days for BLCC-treated VLUs and 133 days for CCSA/SA-treated VLUs. There was a 26% reduction in time to wound healing in the BLCC-treated group. Additionally, the BLCC-treated group had a significantly greater frequency of wound closure than the CCSA/SA-treated group at weeks 8, 12, 18, and 24 (31% vs 20%; 44% vs 33%; 57% vs 49%; and 65% vs 57%, respectively). The probability of healing the BLCC-treated VLUs was 20% greater than the comparator over 2 years of observation at each timepoint.

In summary, this study using real-world data demonstrated that BLCC accelerated wound closure and showed improvements in the probability, speed, and incidence of healing compared with CCSA/SA in the treatment of VLUs.

Reference:

1. Raffetto JD, Ligi D, Maniscalco R, Khalil RA, Mannello F. Why Venous Leg Ulcers Have Difficulty Healing: Overview on Pathophysiology, Clinical Consequences, and Treatment. J Clin Med. 2020;10(1):29.

Poster CR-034 was featured at SAWC Fall 2021.