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临床试验/NCT03289247
NCT03289247已完成不适用

A Prospective Single-blinded Randomized Controlled Study Evaluating Efficacy of Tissue Adhaesive in Wound Closure Following Primary Total Knee Arthroplasty

Hvidovre University Hospital0 个研究点目标入组 30 人开始时间: 2015年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
30
主要终点
Wound discharge during stay

研究概览

简要总结

The study's primary objective is to compare the following parameters between wound closure following primary TKA with and without supplement tissue adhesive (Leukosan®):

详细描述

Prolonged wound drainage following total joint replacement surgery has been shown to be a predictor of Periprosthetic Joint Infection (PJI) 1-3. Several studies have highlighted this subject, and estimates of the risk of postoperative infection range from 1.3% to 50% among patients with persistent wound drainage 4. Such infections can be one of the most challenging complications following joint replacement surgery and is one of the leading causes of revision surgery following primary hip and knee arthroplasty 5,6.

Several patient-related factors have been associated with delayed wound healing and increased risk of infection following joint replacement surgery. Obesity 4,7, diabetes 8, smoking 9,10 and autoimmune disease 11 have been shown to have a detrimental effect on wound healing. Recently there has also been reports that patients with hypertension 12 have impaired wound healing following total hip arthroplasty (THA) and total knee arthroplasty (TKA).

Surgery related factors such as surgical approach, pneumatic tourniquet time and use of peri-articular local anesthesia have also been shown to have an effect on postoperative wound oozing 9,13.

Finally, several pharmacological factors, such as thromboembolic chemoprophylaxis 4, steroid treatment 9,14 and possibly statins 15,16 might also influence wound healing.

In recent years tissue adhesives for wound closure have been introduced as a replacement or a supplement to conventional closure techniques. Currently very few studies investigate the effect of such tissue adhesives in Total Knee Arthroplasty, and high quality randomized controlled trials (RCT) are lacking.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

盲法说明

Investigator evaluating primary outcome is blinded to intervention

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Regular

No Intervention

Regular closure:

The standard 3-layer closure is performed using: 1) size 2 coated VICRYL® Plus Antibacterial suture for capsule closure 2) size 2-0 coated VICRYL® Plus Antibacterial suture for subcutaneous tissue closure and 3) stainless steel stables using PROXIMATE® Fixed-Head stapler for cutaneous closure.

Additional tissue adhaesive

Experimental

The standard 3-layer closure is performed using: 1) size 2 coated VICRYL® Plus Antibacterial suture for capsule closure 2) size 2-0 coated VICRYL® Plus Antibacterial suture for subcutaneous tissue closure and 3) stainless steel stables using PROXIMATE® Fixed-Head stapler for cutaneous closure. tissue adhesive (Leukosan®) is applied on top of the staples according to manufacturer instructions. One layer (one tube) of tissue adhesive is applied following air-drying for 30 seconds, followed by a placement of a second layer with a second layer (one tube), and a second air-drying period of 60 seconds

干预措施: tissue adhesive (Leukosan®) (Device)

结局指标

主要结局

Wound discharge during stay

时间窗: 3 days post op

The wound will be defined as actively oozing, if the standard bandage Mepilex Border Post-op®, is soaked to the border. Bandages soaked to the border will be replaced. Number of replaced bandages for each knee will be recorded.

次要结局

  • ASEPSIS score(3 weeks post op)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kirill Gromov

MD, PhD, Ass. professor

Hvidovre University Hospital

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