Early clinical performance of an adaptive self-assembling barrier scaffold in nonhealing chronic wounds: a review of six cases

Abstract

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