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心脏手术中开放大隐静脉采集后预防性负压伤口治疗的安全性和有效性:一项可行性研究。

Safety and efficacy of prophylactic negative pressure wound therapy following open saphenous vein harvest in cardiac surgery: a feasibility study.

作者信息

Lee Arthur J, Sheppard Christina E, Kent William D T, Mewhort Holly, Sikdar Khokan C, Fedak Paul W M

机构信息

Department of Surgery, Division of Cardiac Surgery, University of British Columbia, Vancouver, Canada.

Department of Cardiac Sciences, Libin Cardiovascular Institute of Alberta, University of Calgary, Calgary, Canada.

出版信息

Interact Cardiovasc Thorac Surg. 2017 Mar 1;24(3):324-328. doi: 10.1093/icvts/ivw400.

DOI:10.1093/icvts/ivw400
PMID:28025309
Abstract

OBJECTIVES

Surgical site complications following great saphenous vein (GSV) harvest presents a significant risk of morbidity. Negative pressure wound therapy (NPWT) has shown promise in the treatment and prophylaxis of open wounds and surgical incisions but has not been studied following GSV harvest. We performed a feasibility study examining the use of NPWT following GSV harvest for coronary bypass surgery.

METHODS

Sixty-four patients were recruited in this single-centre, single-blind, randomized controlled trial. The primary endpoint assessed feasibility by examining rates of device complication and malfunction. Secondary endpoints included rates of surgical site infection, lower leg complications, discharge date, and quality of life at discharge and 6 weeks. NPWT was delivered using the Prevena NPWT device.

RESULTS

There were no complications associated with NPWT which required intervention aside from discontinuation. NPWT was tolerated in 91% (30/33) of patients for the duration of treatment with an average of 4.8 days (±1.45 days). Device malfunction which required discontinuation was 6% (2/33) and involved a malfunctioning pressure sensor and did not affect patient care or present safety concerns. One patient had allergic contact dermatitis to the adhesive and had the device removed. NPWT patients had an earlier date of discharge (6 vs 10 days, P = 0.008), increased ability for self-care ( P = 0.0234) and quality of life ( P = 0.039) at initial assessment, and increased mobility at initial and follow-up assessment ( P = 0.0117 and 0.0123).

CONCLUSIONS

The use of NPWT following GSV harvest is safe, well tolerated and improves postoperative recovery with prolonged impact on mobility at 6 weeks.

CLINICAL TRIAL REGISTRATION

https://clinicaltrials.gov/ct2/show/NCT01698372 ; registration number: NCT01698372.

摘要

目的

大隐静脉(GSV)采集后的手术部位并发症具有较高的发病风险。负压伤口治疗(NPWT)已显示出在治疗和预防开放性伤口及手术切口方面的前景,但尚未在GSV采集后进行研究。我们进行了一项可行性研究,以检验在冠状动脉搭桥手术中GSV采集后使用NPWT的情况。

方法

在这项单中心、单盲、随机对照试验中招募了64名患者。主要终点通过检查设备并发症和故障发生率来评估可行性。次要终点包括手术部位感染率、小腿并发症、出院日期以及出院时和6周时的生活质量。使用Prevena NPWT设备进行NPWT治疗。

结果

除停用外,NPWT未出现需要干预的并发症。91%(30/33)的患者在平均4.8天(±1.45天)的治疗期间耐受NPWT。需要停用的设备故障发生率为6%(2/33),涉及压力传感器故障,未影响患者护理或引发安全问题。一名患者对粘合剂发生过敏性接触性皮炎,移除了设备。NPWT患者出院时间更早(6天对10天,P = 0.008),在初始评估时自理能力增强(P = 0.0234)且生活质量提高(P = 0.039),在初始和随访评估时活动能力增强(P = 0.0117和0.0123)。

结论

GSV采集后使用NPWT是安全的,耐受性良好,可改善术后恢复,并在6周时对活动能力产生长期影响。

临床试验注册

https://clinicaltrials.gov/ct2/show/NCT01698372 ;注册号:NCT01698372。

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