The Use of Cryopreserved Human Skin Allograft for the Treatment of Wounds With Exposed Muscle, Tendon, and Bone

Thomas C. Wilson, DPM; Jessica A. Wilson, DPM; Brandon Crim, DPM; Nicholas J. Lowery, DPM

Disclosures

Wounds. 2016;28(4):119-125. 

In This Article

Abstract and Introduction

Abstract

Background. Wounds with exposed bone or tendon continue to be a challenge for wound care physicians, and there is little research pertaining to the treatment of these particular wounds with allograft skin. The purpose of this study was to evaluate the effectiveness and safety of a biologically active cryopreserved human skin allograft for treating wounds with exposed bone and/or tendon in the lower extremities.

Methods. Fifteen patients with 15 wounds at a single hospital-based wound care center were included in the study. Eleven wounds had exposed bone, 1 wound had exposed tendon, and 3 wounds had exposed bone and tendon. Standard treatment principles with adjunctive cadaveric allograft application were performed on all wounds in the study.

Results. In this study 14/15 (93.3%) of the wounds healed completely. The mean duration of days until coverage of the bone and/or tendon with granulation tissue was 36.14 (5.16 weeks) (range 5–117 days). Mean duration to complete healing of the wound was 133 days (19 weeks) (range 53–311 days). The mean number of grafts applied was 2. There were no adverse events directly related to the graft. Zero major amputations and 1 minor amputation occurred.

Conclusion. This study found biologically active cryopreserved human skin allografts to be safe and effective in treating difficult wounds with exposed bone and/or tendon. To the authors' knowledge, this is the largest study to date focused on the utilization of allograft skin as an adjunct therapy for lower extremity wounds with exposed tendon and/or bone.

Introduction

Chronic lower extremity wounds are a significant health concern and are a cause of morbidity for patients living with them, whether or not diabetes mellitus is a contributing factor. There is a 0.18%-2.00% prevalence of lower extremity wounds in the adult population worldwide,[1] the etiology of which may be vascular (ie, venous, arterial, or mixed), neurotrophic, lymphatic, malignant, inflammatory, traumatic, or infectious. The majority of lower limb ulcerations are related to venous etiology.[2]

Since the aging population is increasing, as well as the prevalence of diabetes mellitus, there is a subsequent increase in the incidence of chronic lower extremity ulceration. An estimated 29.1 million people in the United States have diabetes mellitus,[3] and the estimated lifetime incidence of a diabetic foot ulcer is 25%.[4] Diabetic foot ulcers continue to be a major cause of morbidity and immobility and are a leading cause of nontraumatic lower extremity amputation.

Wound care specialists may utilize advanced biologic agents and skin substitutes for the treatment of chronic, nonhealing wounds. These advanced biologic agents may include bioengineered skin substitutes, cryopreserved skin allografts, cryopreserved placental membranes, acellular collagen, and recombinant growth factors.

Wounds with exposed bone or tendon continue to be a major challenge for wound care physicians. Human skin allografts have traditionally been utilized in the treatment of patients with burns, but have also been used for these difficult wounds with exposed tendon and bone to aid in forming granulation tissue and coverage.[5,6] Snyder et al[5] found that cadaveric allografts prevented desiccation, controlled infection, promoted granulation tissue, and reduced pain in nonhealing ulcers. However, there has been little continued research pertaining to the treatment of wounds with exposed tendon and/or bone with allograft skin over the past several years.

TheraSkin (Soluble Solutions, LLC, Newport News, VA) is a biologically active cryopreserved human skin allograft harvested from tissue donors within 24 hours of death and minimally processed to preserve the components of real human skin. It contains epidermal and dermal layers rich in type I, III, and IV collagen. It also contains a mature extracellular matrix, which is the source of growth factors and cytokines that are necessary in biological wound healing.[7]

The primary aim of this study is to evaluate the effectiveness and safety of a biologically active cryopreserved human skin allograft for treating lower extremity wounds with exposed bone and/or tendon. The authors hypothesized that the use of human skin allograft would effectively aid in coverage and healing of these types of wounds.

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