Mathy Jon A, Patel Alpesh U C, Buan John S, Ustin Jeffrey, Martin Robin
Plastic and Reconstructive Surgery Department, Middlemore Hospital, Auckland, NZL.
Department of Surgery, School of Translational Medicine, Monash University, Melbourne, AUS.
Cureus. 2025 Jun 16;17(6):e86148. doi: 10.7759/cureus.86148. eCollection 2025 Jun.
Background Closed incision negative pressure wound therapy (ciNPWT) is a successful strategy to improve surgical outcomes. However, its use can be limited by the cost of electrically-powered ciNPWT systems, especially in developing countries. A novel negative pressure wound therapy (NPWT) device that utilizes a chemical reaction to create negative pressure promises to be significantly less costly. Method A first-in-human clinical study was completed to evaluate the safety and performance of a novel ciNPWT device (NCT04488666). The primary endpoint was the longevity of the delivery of negative pressure to the wound over seven days. Wound healing was assessed on day seven and day 30. Assessment of the scar quality on day 14 and day 30, exudate management, and ease of use were also undertaken. Results A total of 23 patients were enrolled in the study (mean age 65.0±11.9 years; mean BMI 30.9±6.8 kg/m with a mean wound length of 7.6±2.6 cm, predominantly in elective cutaneous surgery and spinal surgery procedures. The new device was used to maintain negative pressure and manage wound exudate for a mean of 6.3±1.6 days per incision. The mean number of devices used per incision was 1.2±0.5. The Additional treatment; Serous discharge; Erythema; Purulent exudate; Separation of deep tissues; Isolation of bacteria; and Stay as inpatient for a prolonged period (over 14 days) or ASEPSIS and the Patient and Observer Scar Assessment Scale (POSAS) scores indicated overall normal healing and scar quality. There were a total of nine adverse events in five patients. Wounds treated with the new device were not painful. Participant and clinician assessments showed that the devices were easy to use in the hospital and easy to manage at home with routine activities. The device made no audible sound during its use. Conclusion A novel, chemically-generated incisional negative pressure device performed effectively in clinical practice and was shown to be convenient and easy to use. Future studies to assess the effects on surgical site complications are warranted.
背景 闭合切口负压伤口治疗（ciNPWT）是改善手术效果的一种成功策略。然而，其应用可能会受到电动ciNPWT系统成本的限制，尤其是在发展中国家。一种利用化学反应产生负压的新型负压伤口治疗（NPWT）设备有望显著降低成本。方法 完成了一项首次人体临床研究，以评估一种新型ciNPWT设备的安全性和性能（NCT04488666）。主要终点是伤口负压输送持续7天的时长。在第7天和第30天评估伤口愈合情况。还在第14天和第30天评估瘢痕质量、渗出液管理情况以及易用性。结果 共有23名患者纳入该研究（平均年龄65.0±11.9岁；平均体重指数30.9±6.8kg/m²，平均伤口长度7.6±2.6cm，主要用于择期皮肤手术和脊柱手术）。新设备用于维持负压并管理伤口渗出液，每个切口平均使用6.3±1.6天。每个切口使用的设备平均数量为1.2±0.5。额外治疗；浆液性渗出；红斑；脓性渗出物；深部组织分离；细菌分离；以及长时间住院（超过14天）或无菌情况和患者及观察者瘢痕评估量表（POSAS）评分表明总体愈合正常且瘢痕质量良好。共有5名患者出现9起不良事件。用新设备治疗的伤口不痛。参与者和临床医生评估表明，该设备在医院易于使用，在家中进行日常活动时也易于管理。该设备在使用过程中无 audible sound。结论 一种新型的化学产生的切口负压设备在临床实践中表现有效，且方便易用。有必要进行进一步研究以评估其对手术部位并发症的影响。 （注：原文中“audible sound”未明确中文释义，可根据上下文推测为“可听见的声音”，但不确定此处是否有误，按照要求未添加解释说明直接翻译）
