(CS-001) Use of a Synthetic Hybrid-Scale Fiber Matrix* to Augment Lower Extremity Limb Salvage Procedures

Delayed healing of foot ulcers can often lead to lower extremity amputation. Life expectancy after a lower extremity amputation is typically around 3 years [1]. New therapies are needed to aid in the ulcer healing process and augment limb salvage procedures. A synthetic hybrid-scale fiber matrix*, with a structure similar to native human extracellular matrix [2], is gaining popularity in the treatment of chronic ulcers and surgical wounds. This present case series investigates the use of the synthetic hybrid-scale fiber matrix in limb salvage procedures.

Methods:

A retrospective study of three patients with nonhealing diabetic foot ulcers was conducted. Each patient underwent percutaneous elevating lesser metatarsal osteotomy surgery with excisional ulcer debridement. Two patients also had a gastrocnemius recession performed with the elevating osteotomies for surgical offloading of their nonhealing wound sites. At the time of surgery, patients received one application of the synthetic hybrid-scale fiber matrix to the ulcer site for augmentation of their limb-salvage procedures. Ulcer re-epithelialization was monitored at follow up visits.

Results:

Three male patients with diabetes mellitus type II were included in the present study. Two patients underwent elevating 5^th metatarsal osteotomy procedures, and one underwent an elevating 3^rd metatarsal osteotomy procedure. Two patients also had a gastrocnemius recession performed.  All three ulcers underwent excisional debridement at the time of surgery, and the synthetic hybrid-scale fiber matrix was applied to the wound bed. The average starting ulcer size was 2.9cm² and had an average depth of 0.2cm. Each patient received one application of the synthetic hybrid-scale fiber matrix and all ulcers fully re-epithelialized in an average of 27 days.

Discussion:

Complete ulcer re-epithelialization was observed in all three cases treated with the synthetic hybrid-scale fiber matrix. The positive results seen in this pilot case series demonstrate the efficacy of the synthetic hybrid-scale fiber matrix in the augmentation of wound salvage procedures.

Trademarked Items: *Restrata® Acera Surgical, Inc., St. Louis, Missouri

References: 1. Beyaz S, Güler ÜÖ, Bağır GŞ. Factors affecting lifespan following below-knee amputation in diabetic patients. Acta Orthop Traumatol Turc. 2017;51(5):393-397. doi:10.1016/j.aott.2017.07.001
2. MacEwan MR, MacEwan S, Kovacs TR, Batts J. What makes the optimal wound healing material? A review of current science and introduction of a synthetic nanofabricated wound care scaffold. Cureus. 2017 Oct 2;9(10):e1736. doi: 10.7759/cureus.1736.