Karki Bishal, Rai Shankar Man, Nakarmi Kiran, Laminchhane Apar, Maharjan Niran, Giri Piyush, Pathak Kamal, Spielman Amanda, Kung Tiffany H, Ludwig Cassie A
Department of Burns, Plastic, and Reconstructive Surgery, Kirtipur Hospital, Public Health Concern Trust-Nepal, Kathmandu, Nepal.
Healyx Labs, Inc., Mountain View, Calif.
Plast Reconstr Surg Glob Open. 2019 Aug 12;7(8):e2334. doi: 10.1097/GOX.0000000000002334. eCollection 2019 Aug.
There is an evident need for Negative Pressure Wound Therapy (NPWT) systems specifically designed for use in resource-constrained settings to aid in the treatment of open wounds.
Prospective single-arm interventional pilot study of 14 patients with complex wounds was conducted at Kirtipur Hospital in Kathmandu, Nepal. A novel NPWT device, the Kyron Suction Unit, was used by 4 plastic surgeons. Primary outcomes were ease of use (10-point Likert scale) and device safety (adverse events recorded). Pain (Visual Analogue Scale score), quality of life (modified EuroQol Derived Single Index scores), and wound dimensions were recorded.
User ratings on the 10-point Likert scale indicated high confidence and ease of use: median confidence setting up the device of 1.0 [interquartile range (IQR), 1.0; mean 2.3], median confidence maintaining the device of 1.0 (IQR, 1.0; mean, 1.5), and median ease of disassembly of 1.0 (IQR, 1.0; mean, 1.4). Significant improvement in Visual Analogue Scale scores ( = 0.03), modified EuroQol Derived Single Index scores ( < 0.001), and a reduction in wound volume [median, 47.25-9.75 cm ( = 0.01)]. Image analysis of wounds pretreatment and posttreatment demonstrated increase in granulation tissue surface area [median, 7.6-28.7 cm ( = 0.003)] and decrease in open wound surface area [median, 48.33-33.6 cm ( = 0.01)].
The Kyron Suction Unit was safe and easily managed by plastic surgeons. The device design promoted access to NPWT, a therapy proven to reduce healing time and decrease complications for patients with open wounds, in a resource-constrained setting.
显然需要专门为资源有限环境设计的负压伤口治疗（NPWT）系统，以辅助开放性伤口的治疗。
在尼泊尔加德满都的基尔蒂普尔医院对14例复杂伤口患者进行了前瞻性单臂干预性试点研究。4名整形外科医生使用了一种新型NPWT设备——凯伦吸引装置。主要结果为易用性（10分制李克特量表）和设备安全性（记录不良事件）。记录疼痛（视觉模拟量表评分）、生活质量（改良欧洲生活质量衍生单指标评分）和伤口尺寸。
10分制李克特量表的用户评分显示出高度的信心和易用性：设置设备的中位信心评分为1.0[四分位间距（IQR），1.0；均值2.3]，维持设备的中位信心评分为1.0（IQR，1.0；均值，1.5），拆卸的中位易用性评分为1.0（IQR，1.0；均值，1.4）。视觉模拟量表评分有显著改善（P = 0.03），改良欧洲生活质量衍生单指标评分（P < 0.001），伤口体积减小[中位值，47.25 - 9.75 cm³（P = 0.01）]。伤口治疗前和治疗后的图像分析显示肉芽组织表面积增加[中位值，7.6 - 28.7 cm²（P = 0.003）]，开放性伤口表面积减小[中位值，48.33 - 33.6 cm²（P = 0.01）]。
凯伦吸引装置安全且整形外科医生易于操作。该设备设计有助于在资源有限的环境中提供NPWT，这是一种经证实可减少开放性伤口患者愈合时间并降低并发症的治疗方法。
