慢性不愈合的伤口对患者健康和医疗保健系统构成严重关切。在全身性合并症和患者不依从性的背景下,慢性伤口的管理变得尤其具有挑战性。
作者评估了专有的自适应自组装屏障支架(aSABS)在复杂慢性伤口的管理和愈合中的性能。
6名具有解剖学和病因学上不同的慢性伤口的患者被考虑使用aSABS治疗,这是在有执照的医疗保健专业人员的监督下处方使用。伤口对各种治疗方案无反应持续8周至20多年。自适应自组装屏障支架每周应用于临床,除了1例每2周应用一次。不需要机构审查委员会的批准,因为aSABS的使用符合美国食品和药物管理局批准的使用适应症。
只有3到6次应用aSABS后,这些伤口在愈合方面表现出显著的改善,伴随着炎症和感染的抑制,肉芽组织形成,和上皮再生。自适应自组装屏障支架还促进了积极的清创术,以去除发炎,感染,和坏死组织,提供有效的伤口管理和出血控制,同时充当保护屏障。此外,aSABS的使用减轻了患者和护理人员在家中进行伤口护理的负担。此外,这种aSABS的使用可能为临床医生提供高敏锐度手术室的替代方案,因为它有助于在低敏锐度门诊诊所环境中清创和处理一些复杂的伤口-这是COVID-19大流行期间特别重要的产品属性,有助于确保及时有效的治疗.
在这项研究中,SABS显示临床利益在短时间内的患者有显著的合并症和不愈合的伤口。aSABS的使用可以通过在低敏锐度门诊诊所环境中促进清创和处理一些复杂伤口,为临床医生提供高敏锐度手术室的替代方案。这些结果可用于为使用aSABS作为伤口护理开始时的治疗的中心方面以及作为先前的标准和高级治疗方案不成功的伤口的救援产品提供令人信服的论据。
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.