The Use of Fetal Bovine Collagen on Chronic Wounds

Abstract and Introduction

Abstract

Objective: As part of a quality assurance project at a large tertiary care surgical program in New York City, the effect of debridement, negative pressure wound therapy, and cellular- and tissue-based products (CTPs) on limb salvage was evaluated based on the following outcomes: freedom from amputation, wound closure, and freedom from readmission. Fetal bovine collagen was among the CTPs evaluated.

Materials and Methods: The data used in this study were derived from a database of all patients who had undergone procedures involving placement of a dermal matrix at the center over a 2.5-year period (January 2016–June 2018). This retrospective analysis included 256 patients who underwent debridement and/or placement of a CTP as part of the treatment course for chronic wounds.

Results: Of the 252 patients identified, 34 required either minor or major all-cause amputation from the initial wound intervention, whereas for 218 patients, there were no recorded amputations through the end of the study period after the initial wound intervention. When fetal bovine collagen was evaluated as an explanatory variable to the presence of future amputation, a statistically significant relationship between the variables was found.

Conclusions: The results of the current data analysis indicate that a treatment algorithm that includes appropriate antibiotic therapy, tangential hydrosurgery, application of fetal bovine collagen, and a short course of negative pressure wound therapy may be a more favorable option to achieve limb salvage, freedom from readmission, and wound closure.

Introduction

Chronic wounds can significantly affect a patient's psychosocial and physical well-being. It is well established that patients with a diabetic foot ulcer (DFU) have a 2-fold increase in mortality compared with those without such ulceration; this mortality rate is further increased if these nonhealing wounds result in later amputation.^[1] Whether this is a marker of disease severity is not entirely clear; the cause and effect of this association remain to be elucidated. Chronic wounds have a large financial effect on the US health care system, with an annual estimated cost of $28.1 billion (low range) to $31.7 billion (midrange) in Medicare spending.^[2] Management of a DFU is thought to account for up to $19 billion of this spending. Similarly, the long-term cost of a chronic wound that progresses to amputation may be higher than that of a chronic wound managed aggressively with limb salvage efforts.^[3]

The mortality rate associated with chronic wounds coupled with the recent emphasis on limb salvage has resulted in an increased desire for superior wound healing products that are reliable; inexpensive; easy to use, obtain, and store; and devoid of serious adverse effects. To meet this need, a variety of cellular- and tissue-based products (CTPs) have been developed to promote healthy granulation tissue in chronic wounds.

As part of a quality assurance project in the department of vascular surgery at a large tertiary care center (New York, NY), the authors of the current study evaluated the use of debridement techniques, negative pressure wound therapy (NPWT), and CTPs in limb salvage efforts based on the following 3 outcomes: freedom from amputation, wound closure, and freedom from readmission. One of the CTPs specifically evaluated was fetal bovine collagen (Primatrix; Integra LifeSciences). This product is an acellular collagen matrix derived from fetal bovine dermis. It is rich in type III collagen and filled with blood-binding cells and growth factors, thereby supporting cellular repopulation and revascularization of the wound.