Early Clinical Performance of an Adaptive Self-Assembling Barrier Scaffold in Nonhealing Chronic Wounds

A Review of Six Cases

Daniel Kapp, MD, PA; Laura Pfendler, PT, DPT, CWS; Lou D'Oro, MD; Randall Wolcott, MD

Disclosures

Wounds. 2022;34(1):20-30. 

In This Article

Abstract and Introduction

Abstract

Introduction: Chronic nonhealing wounds pose a serious concern for patient health and the health care system. Management of chronic wounds becomes especially challenging in the setting of systemic comorbidities and patient nonadherence.

Objective: Authors evaluated the performance of a proprietary adaptive self-assembling barrier scaffold (aSABS) in the management and healing of complex chronic wounds.

Materials and Methods: Six patients with anatomically and etiologically diverse chronic wounds were considered for treatment with aSABS, which is for prescription use under the supervision of a licensed health care professional. The wounds had been unresponsive to various treatment regimens for 8 weeks to more than 20 years. The adaptive self-assembling barrier scaffold was applied in the clinic weekly, with the exception of 1 case in which it was applied every 2 weeks. Institutional Review Board approval was not required because use of aSABS was in accordance with the US Food and Drug Administration-cleared indications for use.

Results: After only 3 to 6 applications of aSABS, these wounds showed notable improvement in healing, accompanied by suppression of both inflammation and infection, granulation tissue formation, and reepithelialization. The adaptive self-assembling barrier scaffold also facilitated aggressive debridement to remove inflamed, infected, and necrotic tissues, providing effective wound management and bleeding control while functioning as a protective barrier. Furthermore, use of aSABS reduced the at-home burden of wound care for patients and caretakers. Additionally, use of this aSABS may offer clinicians an alternative to high acuity operating rooms by facilitating debridement and management of some complex wounds in a low acuity outpatient clinic setting—a particularly crucial product attribute during the COVID-19 pandemic that helped ensure timely and effective treatment.

Conclusions: In this study, aSABS demonstrated clinical benefit in a short period of time in patients with significant comorbidities and nonhealing wounds. Use of aSABS may offer clinicians an alternative to high-acuity operating rooms by facilitating debridement and management of some complex wounds in a low-acuity outpatient clinic setting. These outcomes can be used to make a compelling argument for use of aSABS as a central aspect of treatment at the onset of wound care and as a rescue product for wounds for which prior standard and advanced treatment protocols were unsuccessful.

Introduction

Despite advances in modern medicine, the burden of wound care continues to increase in line with the rising prevalence of chronic wounds and associated diseases, as demonstrated by increased patient morbidity and mortality and related demands for financial and clinical health care resources.[1] According to Nussbaum et al,[2] estimated total Medicare spending for all wound types in 2014 ranged from $28.1 billion to $96.8 billion. Such spending is likely to increase, given increasing health care costs, an aging population, and a sharp rise in the incidence of diabetes and other chronic diseases that predispose patients to wounds and negatively affect healing.[1,3] Examples of chronic wounds include venous leg ulcers, pressure ulcers, diabetic foot ulcers, ischemic ulcers, and nonhealing, infected surgical, and traumatic wounds. Delayed healing of such wounds is usually associated with underlying systemic and metabolic perturbations, such as diabetes, peripheral vascular disease, autoimmune diseases, cancer, and malnutrition.[1]

Care for chronic wounds typically involves removing the necrotic tissue by debridement, applying dressings that maintain a moist wound environment, preventing and managing wound infections, and performing vascular intervention. As circumstances dictate, rational use of advanced wound care therapies is encouraged when wounds do not respond sufficiently to traditional standard care after 4 weeks or more.[4–6] Use of existing products does not always result in meaningful improvements in outcomes, and the wound care community continues to strive to optimize results.

The AC5 Advanced Wound System (aSABS; Arch Therapeutics), a proprietary adaptive self-assembling barrier scaffold, is a recently commercialized, single multimodal solution indicated for the management of partial-thickness and full-thickness wounds, including those that are chronic or surgical in nature.[7] The product is for prescription use under the supervision of a licensed health care professional. It contains a synthetic and bioresorbable self-assembling peptide as its primary component. The product is applied as a liquid that immediately adapts and conforms to the wound bed and creates a physical-mechanical barrier (Figure 1A)[8] while the peptide self-assembles due to the local ionic environment into a 3-dimensional nanofiber network (Figure 1B).[9] This network is bioresorbable, resembles type I collagen, and has a geometry (Figure 1C)[9] and charge density similar to that of extracellular matrix (ECM). The nanofiber network presents a seal against contamination and modulates local inflammation.[10–13] Subsequently, it supports cellular processes required for tissue repair and wound healing.[14,15]

Figure 1.

(A) Contiguous, cohesive adaptive self-assembling barrier scaffold (aSABS) nanofiber network. H&E histological section of a Wistar rat liver after 4 mm punch biopsy and treatment with aSABS; magnification: 20x; scale bar: 2 mm. Central area demarcated as aSABS indicates filled tissue void. (B) Schematic representation of aSABS nanofibril. (C) Electron micrograph of aSABS (original magnification, 15 000x; scale bar, 5 μm).

This report of 6 cases from 3 separate clinics described the performance of aSABS in wounds for which previously applied conventional and advanced wound care treatments were unsuccessful. In all 6 cases, wound healing had been completely stalled for at least 4 weeks before it was deemed to be in the patients' best interests to change the course of therapy. Due to its mechanism of action, ability to naturally conform to diverse wound beds, and utility, aSABS was selected.

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