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临床试验/NCT02342561
NCT02342561已完成不适用

Iodine Impregnated Incision Drapes and Bacterial Recolonization in Simulated Total Knee Arthroplasty. A Controlled Randomized Experimental Trial.

Odense University Hospital2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2014年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Bacterial Quantity

研究概览

简要总结

This study evaluates the effect of Iodine-impregnated self-adhesive plastic drapes (IIAD) on the quantity of skin bacteria, which is a known factor in the development of surgical site infections in orthopedic surgery. 16 patients scheduled for total knee replacement surgery (TKA) are recruited for participation in an intervention performed at the orthopedic ward of Odense University Hospital, Denmark.

Right or left patient knee is randomized to receive draping with IIAD, while the other knee is not draped. Local standard preoperative procedure for knee surgery is then simulated.

After 75 minutes both knee are sampled for bacterial quantity using the cup scrub method and samples are aerobically incubated. The bacterial growth of the IIAD and no-drape group are then compared using nonparametric statistics.

详细描述

Background

Surgical site infection (SSI) is a serious complication to orthopaedic surgery, resulting in re-operation and prolonged recovery (1, 2)

To prevent SSI, prophylactic methods have been introduced as part of procedure in many types of surgery. Prophylactic strategies such as preoperative disinfection using chlorhexidine or iodine solutions with alcohol have been shown to decrease the number of skin bacteria prior to surgical incision or intravenous catheter insertion. (3-7). Creating a completely aseptic environment for the duration of surgery is however impossible, due to the inability of preoperative disinfection to completely sterilize the skin, combined with re-colonization of the patients endogenous flora from hair follicles, sebaceous glands and sweat glands.(6) (8, 9)

The use of self-adhesive plastic drapes was introduced to prevent contamination of the surgical site due to re-colonizing skin flora, by blocking the translocation of bacteria from the skin adjacent to the surgical site into the surgical wound. Self-adhesive plastic incision drapes are in this way designed to work as a barrier, containing skin flora during surgery.

These types of drapes have however been found to be inferior in preventing bacterial SSI, compared to newer drape types that incorporates an antiseptic iodine-complex into the drape adhesive, facing the skin (10, 11) This outcome might be explained by a drape-induced "greenhouse effect" supported by evidence of increased bacterial colonization-rate with the intraoperative use of non-iodine self-adhesive plastic drapes (12, 13). This effect may be a result of relative occlusion of the skin leading to an increase in skin hydration.(14) This increase in bacterial growth has never been demonstrated in iodine impregnated self-adhesive incision drapes (IIAD) and has been contradicted in studies reporting a reduction in re-colonization rate of skin bacteria on the abdomen when IIAD was compared to no draping and non-iodine drapes while other authors reported decrease in surgical wound contamination when IIAD was used preoperatively in abdominal surgery (3, 15)

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

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

入选标准

  • Patient is scheduled for primary knee replacement surgery (TKA).

排除标准

  • Patient age under 50 year
  • Patient is allergic to iodine
  • Patient has received antibiotic treatment within 4 weeks of intervention.
  • Patient suffers from a chronic skin disease with lesions in the knee area
  • Patient has lesions of the skin due to trauma suffered within 1 week of intervention.

结局指标

主要结局

Bacterial Quantity

时间窗: Measured after skin disinfection and 75 minutes after drape application

The bacterial quantity of the skin in sampled using the cylinder sampling method and incubated for 36-48 hours. Manually counted growth is reported as log10 Colony forming units (CFU)/cm\^2

次要结局

  • Description of Bacterial Skin Flora(Samples collected 75 minutes after drape application are analysed)

研究者

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

Nikolaj Milandt

stud. cand. med, BA Clinical Biomechanics

Odense University Hospital

研究点 (2)

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