Effect of a New Purified Collagen Matrix With Polyhexamethylene Biguanide on Recalcitrant Wounds of Various Etiologies

A Case Series

Dimitrios Lintzeris, DO, CWS; Karen Vernon, NP-C; Heather Percise, NP-C; Andy Strickland, RN; Kari Yarrow, RN; Amber White, RN; Mary Gurganus, RN; Susan Sherrod, RN; Kathleen Vergin, RN; Laura Johnson, RN

Disclosures

Wounds. 2018;30(3):72-78. 

In This Article

Abstract and Introduction

Abstract

Introduction. The management of chronic, nonhealing wounds in patients with multiple comorbidities continues to be a challenge for health care practitioners. Chronic wounds typically do not progress through the normal phases of wound healing and generally remain stagnant during the inflammatory phase, resulting in an increase in proteolytic enzymes with degradation of the extracellular matrix. Bacterial biofilm has been documented to be one of the main factors delaying wound healing, resulting in the prolongation of the inflammatory phase.

Objective. In order to control biofilm formation, sequester proteolytic enzymes, and provide a biocompatible scaffold to support healing, the investigators utilize a purified collagen matrix containing polyhexamethylene biguanide (PCMP) in a case series of 9 wounds on 8 patients with multiple comorbidities who did not respond to previous conventional or adjuvant therapy.

Materials and Methods. Wound etiologies included 3 pressure ulcers, 1 diabetic foot ulcer, 1 venous leg ulcer, 2 postsurgical wound dehiscences, 1 ulcer secondary to calciphylaxis, and 1 traumatic wound secondary to hematoma. The average wound size at the first PCMP application was 34.0 cm2, and the wounds were present for an average of 9.2 weeks prior to the first PCMP application.

Results. Patients received an average of 5.8 PCMP applications. Of the 6 wounds that healed, average time to closure from the first PCMP application was 10 weeks. The remaining 3 wounds demonstrated improved wound appearance with 100% granulation tissue and an average area reduction during PCMP treatment of 61.4%.

Conclusions. This case series demonstrated that PCMP along with good wound care supported both wound closure and improvements in wound bed condition and area reduction on recalcitrant, nonhealing wounds of various etiologies.

Introduction

Chronic, nonhealing wounds in patients with multiple comorbidities continue to be a challenge for health care practitioners to manage and are an increasing burden on health care systems worldwide. Indeed, chronic wounds are estimated to affect up to 1% of the Western population; up to 4.5 million people in the United States alone experience chronic lower extremity ulcers.[1,2] By definition, chronic wounds are wounds that fail to proceed through the normal phases of wound healing in an orderly and timely manner. Chronic leg and foot ulcers have been found to last an average of 12 to 13 months and recur in more than half of patients.[1] The impact of chronic wounds can be staggering, leading to significant loss of function, reduced quality of life, and substantial morbidity and even mortality. In fact, 5-year mortality rates due to lower extremity complications of diabetes are similar to or exceed many types of cancers, including those from prostate cancer, breast cancer, and Hodgkin's disease.[3]

Chronic wounds fail to proceed through the normal phases of wound healing (ie, hemostasis, inflammation, proliferation, and remodeling), typically stalling in the inflammatory phase.[1,4,5] The chronic wound environment is characterized by excessive and persistent levels of proinflammatory cytokines, leading to elevated levels of proteases that degrade the extracellular matrix and prolong the inflammatory phase.[1,5–7] This hyperinflammatory, proteolytic environment prevents the wound from progressing into the proliferative phase, resulting in stalled reepithelialization and the formation of defective granulation tissue.[2,6]

Excessive wound bioburden is recognized as an important factor in delaying wound healing.[4] In contrast to planktonic, or free-floating, bacteria, microbes in the chronic wound bed are believed to exist mainly in biofilm communities, which attach to the wound surface and exist in microcolonies enclosed in a protective matrix of polysaccharide material.[8–10] Biofilms differ genotypically and phenotypically from planktonic bacteria, resulting in higher tolerance to antibiotics and to the host immune response.[8,9,11,12] Biofilms have been increasingly implicated in playing a key role in perpetuating the chronic, nonhealing wound environment.[4,8,11,13–15]

Indeed, biofilms have been estimated to be present in nearly 80% of all human infections[16] and have been detected in 60% of chronic wounds.[13] More recently, it has been argued that biofilms exist in all chronic wounds.[4,17,18]

With growing recognition of the role of biofilms in delayed wound healing, the need to effectively manage biofilm in patients with chronic wounds is increasingly appreciated. Debridement is effective at removing biofilm and is an important component of wound management; however, experimental and clinical data indicate biofilm begins to reform within 24 hours after debridement and can fully mature within 3 days.[19] Thus, although beneficial for removing mature biofilms, debridement alone is an insufficient strategy for preventing the reformation of biofilm and promoting healing.[20]

A purified collagen matrix containing a polyhexamethylene biguanide (PHMB) antimicrobial (PCMP; PuraPly Antimicrobial; Organogenesis Inc, Canton, MA) has been developed to support wound healing. This product consists of 2 layers of predominantly Type I collagen matrix that have been purified to inactivate viruses and remove cells and cellular debris. Importantly, the native structure of the collagen matrix is preserved,[21,22] which has been shown to be an important factor in determining a collagen dressing's ability to quench proteolytic enzymes that characterize the chronic wound environment.[7] Further, the matrix is cross-linked and coated with PHMB, enabling it to resist proteolytic degradation and providing a sustained antimicrobial effect. Polyhexamethylene biguanide is an extensively studied antimicrobial with a broad antimicrobial spectrum and no reported cases of antibacterial resistance.[23,24] Unlike some antimicrobials, PHMB is nontoxic to human cells and does not impair the healing process.[25]

The use of PCMP to manage bioburden and support healing in patients with challenging chronic wounds has been described.[26] This paper extends this experience to a series of patients with multiple comorbidities and wounds of various etiologies.

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