1. Multi-centre study demonstrating safety and efficacy of an upgraded sNPWT system on closed surgical wounds.
- Author
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Karlakki, Sudheer L., Evans, Jessica R., Booth, Simon P., Wong, Jason K. F., Wilson, Lyn, Jeffrey, Steven L. A., Makhija, Rohit, Harder, Yves, McNamara, Iain, Reed, Mike, Barnes, David E., Megginson, Sarah, and Gilchrist, Brian
- Subjects
EXPERIMENTAL design ,RESEARCH ,CLINICAL trials ,HUMAN research subjects ,PAIN measurement ,SAMPLE size (Statistics) ,CONFIDENCE intervals ,VISUAL analog scale ,POSTOPERATIVE care ,PATIENT satisfaction ,HEALTH outcome assessment ,NEGATIVE-pressure wound therapy ,INFORMED consent (Medical law) ,T-test (Statistics) ,SURGICAL site infections ,SURGICAL site ,DESCRIPTIVE statistics ,RESEARCH funding ,SOCIODEMOGRAPHIC factors ,DATA analysis software ,PATIENT safety ,LONGITUDINAL method ,MEDICAL needs assessment - Abstract
Background Surgical site complications (SSCs) pose a major post-operative challenge. Single-use negative pressure wound therapy (sNPWT) systems have been shown to be effective for reducing SSCs. An upgraded sN-PWT system (PICOTM 7) with improved functional performance and ease-of-use was assessed in a prospective, single-arm study. The study aimed to assess if the system was a safe and effective therapy for delivering consistent negative pressure. Methods Between November 2018 and May 2019, eligible patients across 11 sites with a closed abdominal or knee arthroplasty incision, skin graft or flap, were enrolled. Postoperatively, patients received sNPWT for up to 7 days with follow-up until 30 days. Endpoints included the ability to maintain a consistent negative pressure for the intended duration, complication rates, clinician and patient usability and satisfaction and serious adverse events. Results The device was capable of delivering consistent negative pressure across all assessed surgical wounds and was statistically equivalent to the reference negative pressure (-80.2 mmHg) (n=46; p=0.002). Low complication rates were observed within 30 days post-surgery. High levels of clinician usability (>90%) and patient satisfaction (95%) were reported. No serious device-related adverse events were reported. Conclusions The study demonstrated the functional performance, favourable safety profile and clinician- and patient-reported satisfaction of this upgraded PICO 7 sN-PWT device across multiple closed surgical wound types. Implications Application of an sNPWT system can lead to improved wound healing outcomes within closed surgical wounds while also demonstrating high levels of clinician and patient satisfaction. [ABSTRACT FROM AUTHOR]
- Published
- 2021
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