Early Clinical Performance of an Adaptive Self-Assembling Barrier Scaffold in Nonhealing Chronic Wounds: A Review of Six Cases

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

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.

The adaptive self-assembling barrier scaffold is supplied as a lyophilized peptide in a complete kit with the sterile contents for reconstitution and application. The preparation instructions are as follows: (1) inspect kit contents, remove vial caps, and swab tops with the alcohol wipe; (2) with a syringe and 18 g hypodermic needle, transfer 1.5 mL of water into the aSABS peptide vial and shake to dissolve; (3) draw solution into a syringe and replace the needle with an 18 g blunt applicator; and (4) apply the solution to the wound in a back-and-forth motion.

For each case reported, aSABS was prepared and applied as described in the instructions for use. Secondary dressings were applied to cover the wound and were changed per standard practice in each clinic. 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 (IRB) reviews and approval were not required because use of aSABS was in accordance with the US Food and Drug Administration-cleared indications for use. Patient consent was obtained by the respective clinicians for use of the images and observations provided.

The cases detailed herein represent a broad spectrum of challenging, nonhealing wounds of varying chronicity ranging from 8 weeks to more than 20 years in duration prior to presentation for treatment with aSABS. Additionally, treatment challenges were compounded by associated complexities and etiopathologies, including high bioburden levels in a chronic pressure ulcer and secondary burn; surgical complications, such as below-knee surgeries and amputations; systemic comorbidities (diabetes, peripheral vascular disease, scleroderma, Raynaud’s phenomenon, chronic deep vein thrombosis); and patient nonadherence. The ability of aSABS to reinitiate and promote normal healing in a wound in which the healing process had been stalled due to inflammation and infection is reflected in the clinical outcomes described.

A summary of the patient histories provided in the Table (Part 1 and Part 2) is followed by individual case reports detailing the background, aSABS treatment regimen, and healing progression as demonstrated by graphical representation and/or images. Qualitative descriptors of the outcomes observed by the clinicians and the effect on quality-of-life–related parameters reported by patients are also presented.

Case 1

A 47-year-old male presented with a history of paraplegia and an ischial decubitus ulcer that had not healed during the prior decade of standard wound care.¹⁶ The wound was subjected to repetitive trauma from the patient’s routine use of heavy farm equipment, which exacerbated the need for wound management. Previous treatment regimens included offloading and topical antimicrobial agents and dressings to address the wound microbiota. Approximately 5 years prior to the start of treatment with aSABS, topical agents and dressings (such as iodoform, antibacterial foam dressing, and silicone absorbent foam dressing) targeting Staphylococcus were used. As the wound aged, the microbiota changed to Pseudomonas and Candida.

After aSABS became commercially available, the clinic treatment protocol transitioned to aggressive surgical debridement (until a bleeding wound bed was visible) with concomitant application of aSABS. The post-debridement wound was packed with iodinated foam and covered with a standard dressing, which was changed 3 times per week at home. Subsequent evaluation of the wound by polymerase chain reaction assays demonstrated reduced Pseudomonas levels and the absence of Candida. During the course of treatment, it was observed that combining aSABS with debridement consistently allowed for a more aggressive debridement procedure while offering bleeding control in the low-acuity clinic setting and without the need for thrombin or sutures. In addition, the nanofiber network appeared to provide a cohesive seal on the wound bed surface after debridement, likely contributing to less biofilm and senescent host cells in the wound microenvironment.

After 3 debridements with concomitant aSABS application performed every 2 weeks, nearly 50% reduction in wound volume was reported (Figure 2); prior to aSABS, in this wound had been refractory to treatment and stalled for more than a decade. The patient self-reported that each dressing change required less packing and that a substantial reduction in drainage and bleeding resulted in more manageable at-home wound care and fewer routine clinic visits. The wound decreased in size and demonstrated decreased exudate, decreased slough, and improved periwound skin appearance with less maceration even though the patient continued to operate heavy farm equipment. This milestone encouraged the patient to adhere to scheduled clinic visits, thus allowing for continued care and healing.

Case 2

A 49-year-old male presented with a chronic open friable wound resulting from the breakdown of severe scarring.¹⁷ The initial injury was an extensive burn across the chest and flank that occurred more than 20 years previously. The wound persisted despite years of management with repeat surgical debridement and use of various products, including an antibiofilm gel, nonadherent foams, and dressings. The extreme friability of the wound, coupled with its presence in areas prone to continued friction from clothing, resulted in frequent and extensive bleeding. Laboratory analysis confirmed the suspicion that the friable tissue resulted from the wound microbiota; the tests also confirmed the presence of polymicrobial biofilm with strong fungal (Aspergillus) and bacterial (Enterococcus faecalis and Corynebacterium jeikeium) components.

At the center in which the patient was treated, effective and aggressive debridement is the first step in the biofilm-focused wound care treatment regimen. Aggressive debridement in this patient's wound was accompanied by application of aSABS once weekly for 4 weeks. The adaptive self-assembling barrier scaffold formed a clear conforming seal on the wound and remained affixed to the surface of the irregular wound bed, even in the presence of copious bleeding (Figure 3A). At the time of the second debridement, the wound bed surface was found to be much less friable and, therefore, produced far less bleeding.

After 2 interventions, the wound bed quality improved, exhibiting a healthier tissue appearance, less exudate, less accumulation of slough on the wound surface, and new granulation buds (Figure 3B). More important for the patient was the cessation of intermittent bleeding episodes, which alleviated the burden of at-home wound care. Because the wound was embedded in a significant scar, wound contracture was not expected; thus, reduction in wound size could not be followed as a metric for healing.

The aggressive debridement made possible by the application of the aSABS facilitated the removal of the infected granulation tissue. This reduction in the wound bioburden likely helped address a major stimuli contributing to the chronicity and severity of this type of wound. Subsequently, aSABS appeared to have enabled healing of this stalled refractory burn wound, thus improving the patient’s quality of life.

Case 3

A 66-year-old female who underwent emergency vascular bypass surgery for a limb-threatening posterior tibial ischemia developed a nonhealing surgical site wound as the result of local infection and wound dehiscence.⁹ The patient was treated with wet-to-dry dressings for 6 weeks, with no change in the wound. She was subsequently treated with a collagenase ointment for 2 weeks, followed by an unsuccessful skin graft. The surgeon decided to perform excisional debridement and concomitant application of aSABS once weekly for 3 weeks. Because of the peripheral arterial disease, the patient was not a candidate for compression dressings.

Surgical excisional debridement was performed to prepare the wound bed, followed by application of aSABS. A nonadherent, petrolatum-based fine mesh gauze dressing containing 3% bismuth tribromophenate was then applied, followed by sterile gauze and Kerlix dressing (Cardinal Health). The surgeon observed that using aSABS promoted the formation of healthy granulation tissue, thus allowing the patient to resume at-home wound care. The development of a stable granular wound bed and wound closure were achieved without the need for additional skin grafts. The progression of wound healing is illustrated in Figure 4.

In this case study of a complex surgical wound, aSABS restarted the previously stalled healing process. The results indicate that aSABS may obviate the need for continued costly treatments and procedures, thus reducing the costs of lower extremity wound care while improving the patient’s quality of life.

Case 4

A 64-year-old male with diabetes and a history of nonadherence to medical therapy and prior transmetatarsal amputation (TMA) of the right foot presented with severe sepsis and gas gangrene of the left foot. The patient required fluid resuscitation, sepsis treatment per protocol guidelines, and emergent guillotine TMA of the left foot, which resulted in an open wound measuring 8 cm² × 7 cm². Despite approximately 50 weeks of treatment, frequent debridement, 5 applications of a placental-based product containing human amnion and chorion membrane, and applications of other products, the wound did not heal. It stalled at 3 cm² × 2 cm² in size, and hypertrophic peripheral soft tissue with a fibrotic base occurred.

It was determined that a change in treatment was necessary; aSABS was applied once weekly for 4 weeks with aggressive surgical debridement. The wound responded well, and the previously stalled healing process restarted. After 4 weeks of aSABS treatment, the wound demonstrated excellent wound bed granulation, diminished hypertrophic margins, and approximately 95% wound healing. Photographs of the wound before and after aSABS treatment are shown in Figure 5. Furthermore, aSABS was observed to possess hemostatic properties, which enabled both more aggressive wound debridement and management of bleeding without the need for additional modalities.

The overall results provided clinical evidence of wound healing and hemostasis in a previously clinically stalled and challenging wound in a patient with diabetes and a history of medication nonadherence.

Case 5

A 59-year-old female presented with a nonhealing trophic ulcer on the left lateral malleolus.¹⁸ The patient had a complex medical history with multiple systemic comorbidities, including lupus, scleroderma with Raynaud’s phenomenon, small vessel peripheral vascular disease, and right below-knee amputation secondary to small vessel disease and a prior nonhealing ulcer. The current ulcer had persisted for 4 years despite extensive standard and advanced wound care interventions, including debridement, moist wound treatment, nitropaste, and skin substitutes.

Management of the ulcer with aSABS was initiated following excisional debridement. The wound was then covered with a nonadherent, petrolatum-based fine mesh gauze dressing containing 3% bismuth tribromophenate and a dry secondary dressing. Subsequent applications of aSABS were performed weekly, for a total of 3 applications. Treatment with the first 2 applications of aSABS showed significant healing of the ulcer, with a greater than 90% reduction in wound volume. At the patient’s last visit on day 19, the wound was completely epithelialized, with 100% closure. The course of healing progression is shown in Figure 6, as demonstrated by a photograph of the wound after 3 weeks of treatment and a graphical presentation of wound size data.

Complete healing of this previously nonhealing trophic ulcer, which had been unresponsive to multiple wound management regimens during the prior 4 years, was achieved in less than 1 month with 3 weekly applications of aSABS. The outcome can be considered notable due to the patient’s multiple concurrent vascular and autoimmune diseases, which are known to hinder wound healing progression and that likely contributed to the failure of previously used wound care regimens.

Case 6

A 51-year-old male presented with a nonhealing surgical wound of the pretibial right lower leg.¹⁹ The patient underwent Mohs surgery for squamous cell carcinoma 9 weeks prior to presenting to the clinic. The patient had a history of hypertension, dyspnea, chronic deep vein thrombosis, chronic right pulmonary artery thrombosis, and idiopathic mediastinal fibrosis. Previous wound care treatment included the use of various topical antibiotics and nonadhesive pads.

On admission, the wound had a moderate amount of slough and measured 2.6 cm². The following week, treatment with aSABS was initiated immediately after excisional debridement, and then covered with a nonadherent, petrolatum-based fine mesh gauze dressing containing 3% bismuth tribromophenate. Unna boot compression was applied. This regimen was repeated once weekly for a total of 4 applications. During the course of treatment, granulation tissue formation increased, and by the final application, the wound surface area had decreased by 90% (Figure 7). Complete wound healing was achieved by the final follow-up visit at week 6. Use of excisional debridement and treatment with aSABS stimulated healing progression of this stalled wound that had not responded to 2 months of standard therapy.

Wound healing is a complex and dynamic process. It can be delayed for many reasons, including intrinsic factors, such as wound characteristics (location, wound size), patient characteristics (advanced age, obesity, poor nutrition), and systemic comorbidities (diabetes, compromised renal function, vascular disease), and exposure to extrinsic factors that adversely affect wound repair, such as microorganisms, physical aggravation, and administered medications or treatments. The currently accepted paradigm for delayed wound healing involves the wound becoming stuck in a hostile environment during the inflammatory phase of healing.²⁰

Manifestations of healing complications may include dehiscence, hypertrophic scars, scar contracture, exudation, infection, tissue ischemia, and necrosis; in some cases (eg, diabetic foot ulcers), these may lead to recurrence, amputation, or mortality.^21-23 Despite the number of wound management options available, many wounds do not respond to treatment. The burden on the families and caretakers of patients resulting from failed treatment should not be minimized.²⁴ Advances on multiple fronts, including biomaterials, biologics, novel procedures, and the tools and markers to better understand wound pathophysiology, have aided the development of novel wound care and skin regeneration technologies. The advanced treatment modalities include bioactive molecules, growth factors, gene and cell therapies, skin substitutes, collagen or similar biopolymers, hyperbaric oxygen, lasers, electrical stimulation, and negative pressure wound therapy.^21-23 The potential for these approaches to influence the healing of chronic, refractory wounds hinges on their ability to interrupt the stalled healing process and promote resumption of the normal healing process.

Previous studies in various preclinical models have shown the ability of aSABS to affect multiple events in the wound repair process. Csukas et al⁸ reported on rapid hemostasis with use of aSABS regardless of anticoagulation status in a rat liver punch biopsy model. In porcine models of second-degree burn wounds and full-thickness wounds, application of aSABS resulted in reduced inflammation, lower total bacterial counts, and higher rates of both granulation tissue formation and reepithelialization compared with controls.^10-12 The anti-inflammatory effects of aSABS were also demonstrated in a lipopolysaccharide-induced inflammation model of eye injury.¹³ An increase in the steady-state mRNA levels of epidermal growth factor, keratin 6, keratin 17, and vascular endothelial growth factor was observed in wounds managed with this self-assembling peptide compared with those managed with saline (control group), which correlated with the histological findings of higher reepithelialization rates and increased granulation tissue formation.¹⁰ The clinical results and quality-of-life outcomes in the cases described in the present study, which were observed by the clinicians and patients alike, could be explained by the unique attributes of aSABS noted in the aforementioned preclinical studies.

The use of debridement prior to application of subsequent dressings or procedures has been widely recognized as the optimal strategy to achieve improved healing outcomes in the management of chronic wounds.^1,21,25 As discussed in the individual case studies in the present study, aSABS better enabled the use of aggressive debridement procedures necessary to completely remove the necrotic wound tissue by providing a remarkable degree of wound management and bleeding control. As a result, it was possible to complete wound management in a low-acuity clinic setting and without the need for thrombin or sutures, which would otherwise have been used for many of these procedures. The immediate bleeding control afforded by aSABS, even in the presence of antiplatelet therapy, was demonstrated in a prior clinical study of acute shave excision wounds.²⁶ The cases presented herein further support those findings, even in the presence of more challenging chronic wounds and complex patient subsets, as well as regardless of the wound age, depth, or severity (eg, a 10-year-old pressure ulcer with ongoing repetitive trauma or a 1-year-old refractory post-TMA wound in a patient with diabetes). Of note, bleeding cessation was also observed long after the debridement procedure, alleviating the patient’s at-home routine, as seen in the case of the patient with the extremely friable open wound secondary to an extensive burn sustained 20 years earlier.

Furthermore, by facilitating aggressive debridement, use of aSABS also allowed near-complete removal of the biofilm of surface-associated bacteria and the infected wound tissue, thus reducing the wound bioburden, which is among the major culprits in wound chronicity. Although the clinical diagnosis of wound biofilm remains controversial, it is now recognized that biofilms are present in 60% to 100% of chronic wounds, a position supported by the World Union of Wound Healing Societies.²⁷ These biofilms maintain a state of chronic inflammation that can damage surrounding tissue. The hyperactivation of local inflammatory processes and the physical obstruction to wound closure caused by the bacterial biofilms pose a serious threat to healing, thus making both the removal of biofilm and control of excessive inflammation a high priority.^28-31 A broad range of biofilm management strategies, including local and systemic antibiotics, surgical debridement, and recent technologies, such as topical oxygen therapy, have been used in an attempt to address the problem of wound biofilm.²⁸ Although the wound microbiota were not quantified for all cases in the present study, treatment with aSABS appeared to have had a favorable effect on the bioburden in cases in which such evaluations were made, which suggests that aggressive debridement of the wound allowed for the removal of the infected tissue, thus helping return the wound to the normal healing cycle.

The ability of aSABS to form a clear, conforming seal of a nanofibril network that remained affixed to the surface of an irregular wound bed provided a protective moisture-donating barrier on and around the wound tissue. The effect of a moist wound environment on multiple wound healing elements has been documented in the literature; this would include augmenting the epithelialization process by faster and easier migration of epidermal cells, encouraging prolonged presence of proteinases and growth factors, improving the inflammatory and proliferative phase, and enhancing angiogenesis.^32-34 Consequently, several types of advanced wound dressings have been developed, including occlusive or semi-occlusive advanced wound dressings, odor-absorbent dressings, scaffold dressings, bioactive dressings, and antibacterial dressings.²⁰ Achieving moisture balance that allows for wound reepithelialization without excessive exudate is essential to reducing inflammation and promoting healing. In at least 2 of the cases studied herein in which such observations were made, a reduction in wound drainage and exudate levels was noted while the protective barrier function was maintained and granulation tissue was formed.

In addition to the reduction of infection and inflammation, other distinguishing features of normal wound healing (ie, reduction of wound hypertrophic margins, wound contracture, or granulation bed formation) were noted, supporting that aSABS becomes an ECM-like network, thus creating a microenvironment for favorable cellular events, such as adhesion, migration, and proliferation of healthy host cells in the wound milieu and subsequently facilitating repair of the damaged wound tissue. In the context of the etiopathology of the wounds, it is important to note that more than half the cases reported here represented lower extremity wounds. They comprised a surgical site wound from local infection and dehiscence after emergency vascular bypass surgery for tibial ischemia, a wound after Mohs microscopic surgery, a stalled chronic wound after TMA, and a trophic ulcer on the lateral malleolus. The latter 2 cases were also compounded by systemic comorbidities.

Management of lower extremity wounds can pose an enormous challenge to the surgeon. For instance, the repair of below-the-knee lower extremity defects after Mohs surgery that are not amenable to primary closure leads to challenges given the high propensity for complications. Postoperative reactive edema and inflammation can result in a painful and protracted healing course.³⁵ In the context of TMA, many patients often have comorbidities or risk factors such as diabetes mellitus, infrapopliteal disease, history of smoking, and end-stage renal disease; in such cases, wound management can be arduous. Failure rates associated with TMA have been well-documented in the literature and manifest as postoperative complications requiring further surgery, a need for a more proximal amputation, or perioperative hospital mortality.^36-38 The management of trophic ulcers poses substantial difficulty because of the recurrent and nonhealing nature of these ulcers. Management is further complicated by associated systemic pathologies, which often have a disabling effect with devastating complications, such as amputation.³⁹ Desired outcomes are often elusive, despite the current availability of multiple options to treat lower extremity wounds. Consequently, the need for improved technologies to reduce the need for amputation procedures and potential mortality remain.

Even among the complex lower extremity wounds reported in the present study, aSABS demonstrated remarkable healing progression, which was particularly impressive considering the presence of multiple systemic comorbidities or medication nonadherence, either of which could hinder wound repair. The adaptive self-assembling barrier scaffold offered 2 valuable and practical benefits in the management of chronic wounds. First, the hemostasis and wound management properties enabled aggressive surgical debridement. Second, the assembled aSABS intercalated with the wound bed, providing a barrier scaffold that augmented host healing. In this study, aSABS demonstrated marked efficacy in the patients with stalled wounds.

The translation of the multipronged mechanistic effects of aSABS to the observed clinical effects reported in these case studies (ie, improved wound quality and tissue appearance, reduced wound size, reduced exudate or accumulation of slough, improved wound granulation, and improved epithelialization), underscores its performance. In addition to the clinical outcomes, the observations reported by the patients during the at-home intervals between the clinic visits included cessation of intermittent bleeding episodes, a noteworthy reduction in wound drainage, and reduced burden of at-home care on patients’ families and caretakers. Finally, in addition to the improvements in healing outcomes, use of aSABS seems to have improved patients’ quality of life and adherence to prescribed treatment regimens.

The clinical performance of aSABS, albeit early and in limited numbers of patients, points to its potential as a single multimodal solution. Self-assembly of the peptide into aSABS as a result of the ionic local wound environment was observed consistently, and the cited benefits occurred independent of the complexity, age, or location of the wounds; the sex, age, or comorbidities of the patients; and the variety of therapeutic approaches to wound management across the 3 clinics. These wounds had not previously healed despite prior attempts to treat them with a variety of wound care modalities, including skin grafts, placental-based products containing human amnion and chorion membrane, and skin substitutes, in addition to standard products and treatment regimens, such as topical antibiotics, antibiofilm gel, or ointments, offloading, and debridement procedures. Given that use of aSABS reinitiated the previously stalled healing processes and facilitated repair in a short duration in these exceedingly complex wounds, it is easy to postulate the effect it could have on healing progression if used as an elective wound healing product at the onset of wound care, rather than or in addition to its use as a rescue product to address the failure of prior treatments, as was done in these cases. More important, use of aSABS allowed management of these complex wounds in an outpatient setting without the need for an operating room; this is a valuable feature both during the COVID-19 pandemic, and any time when resource constraints can lead to negative outcomes by limiting access to operating rooms or resource-intensive technologies. Furthermore, use of aSABS can enable clinicians the ability to better deploy the Wound Center Without Walls strategy proposed by Rogers et al,⁴⁰ in which wound care is untethered from a physical location while allowing aggressive triage and wound care.

This study is not a prospective case series. Rather, it is a compilation of cases from studies conducted in multiple clinics. Results from these case reports would need to be reproduced in a larger patient population and with well-defined patient inclusion and exclusion criteria, follow-up, and end points.

In this study, aSABS had a marked effect on wound healing by interrupting the stalled inflammatory phase, reducing the bioburden of infected wound tissue, and stimulating the progression of the wound through the proper biological sequence of repair. Also noteworthy was the fast pace of healing (3 weeks in some cases), with only weekly clinic visits and reapplication. Even in patients with considerable systemic comorbidities, use of aSABS resulted in the healing of wounds that had been persistently inflamed and infected and for which other advanced wound products and surgical debridement had been unsuccessful. The clinical observations noted in these cases can be attributed to the multimodal mechanism of aSABS, which includes creating a protective, bioresorbable barrier that conforms naturally to diverse wound beds, modulates inflammation, reduces bioburden, and has a nanofiber network that supports tissue repair, providing utility throughout all stages of wound healing. It was also believed that aSABS improved patients’ quality of life and the at-home burden of wound care for both patients and their caretakers. In addition to potentially providing a favorable effect on patient morbidity and mortality in wound management, broader adoption of this advanced product may reduce the burden on the currently resource-constrained health care system by providing a better option for managing chronic, refractory, or otherwise challenging wounds. A clinical trial comparing the performance and cost-effectiveness of aSABS with currently existing therapies is warranted.

Authors: Daniel Kapp, MD, PA^1,2; Laura Pfendler, PT, DPT, CWS¹; Lou D’Oro, MD³; and Randall Wolcott, MD^4,5

Affiliations: ¹Daniel L Kapp, MD Plastic Surgery & Wound Care, West Palm Beach, FL; ²Wound Care and Chief of Surgery at Palm Gardens Medical Center, Palm Beach Gardens, FL; ³Wayne Memorial Hospital, Honesdale Surgery, Honesdale, PA; ⁴Department of Surgery Texas Tech University School of Medicine, Lubbock, TX; ⁵Director of Southwest Regional Wound Care Center, Lubbock, TX

Disclosure: Dr Kapp and Dr D’Oro are clinical advisors to Arch Therapeutics.

Correspondence: Laura Pfendler, PT, DPT, CWS, Plastic Surgery & Wound Care, 1500 N Dixie Highway, Suite 304, West Palm Beach, FL 33401; LP@drdanielkapp.com; Daniel L Kapp, MD, PA, Plastic Surgery & Wound Care, 1500 N Dixie Highway, Suite 304, West Palm Beach, FL 33401; dlk@drdanielkapp.com