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临床试验/NCT03393819
NCT03393819已完成不适用

Efficacy of Surgical Skin Preparation Solutions in Hip Arthroplasty Surgery

Lakehead University0 个研究点目标入组 105 人开始时间: 2014年10月29日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
105
主要终点
Post-preparation skin swab

研究概览

简要总结

This study will assess the efficacy of two of the most commonly used surgical skin-preparation solutions: Chloraprep (chlorhexidine-alcohol) and Duraprep (iodine-alcohol) at eliminating bacteria from the hip site by evaluating the residual bacteria present following surgical skin-preparation.

详细描述

Post-operative infections, although rare, can lead to significant patient morbidity and cost. A potential risk factor for the development of post-operative wound infection is the amount of bacterial skin flora present at the operative site at the time of surgery. Therefore, the use of an effective anti-microbial preoperative skin-preparation solution is essential in preventing the contamination of the surgical site and in turn the surgical wound.

Several different types of anti-microbial skin preparation solutions are presently used pre-operatively. However, there is currently no consensus on which solution is superior. Previous studies have investigated the efficacy of commonly used solutions in the shoulder, foot and spine, however the bacterial flora from these areas are likely different from the hip region. Thus the findings in the literature are not necessarily applicable to surgery involving the hip.

Because of the potentially devastating consequences of a surgical wound infection, ensuring effective skin preparation prior to surgery is critical. Therefore the identification of a superior skin-preparation solution for the elimination of bacterial pathogens, specific to the hip region, could potentially have considerable impact on the clinical care of patients undergoing hip arthroplasty surgery.

This study will assess the efficacy of two of the most commonly used surgical skin-preparation solutions: Chloraprep (chlorhexidine-alcohol) and Duraprep (iodine-alcohol), at eliminating bacteria from the hip site by evaluating the residual bacteria present following surgical skin-preparation.The primary outcome is as follows: positive culture rates of residual bacteria following surgical skin preparation. Secondary outcomes that will be evaluated is culture rates post-surgery (following skin closure) and acute (within 3 months) post-operative wound complications.

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 (Outcomes Assessor)

盲法说明

Blinding of the participants and care providers after the assignment of the intervention is not possible as the two solutions are distinct, and one creates a unique discolouration of the skin. Those performing the laboratory analysis and reporting the results of the bacterial culture of will be blind to which treatment the participant was assigned (i.e. the label will not identify which group the participant belongs to).

入排标准

性别
All
接受健康志愿者

入选标准

  • Has consented for primary total hip arthroplasty by any of the following orthopaedic surgeons: Drs. Kurt Droll, Dave Puskas or Claude Cullinan
  • Are capable of providing their own consent
  • Are able to adequately communicate in English to undergo informed consent
  • Has provided written, informed consent for the study

排除标准

  • Previous hip arthroplasty
  • Evidence of an open wound at the incision site
  • Evidence of an abrasion in the vicinity of the planned incision
  • Evidence of an active infection at or near the surgical site
  • Evidence of an active infection elsewhere in the body
  • Are chronically immunosuppressed e.g. transplant
  • Is deemed not suitable for the study in the opinion of an investigator

研究组 & 干预措施

Duraprep Surgical Solution

Experimental

Surgical site (hip) is prepared with Duraprep (iodine-alcohol) prior to surgery according to package instructions.

干预措施: DuraPrep (Drug)

Chloraprep Surgical Solution

Experimental

Surgical site (hip) is prepared with Chloraprep (chlorhexidine-alcohol) prior to surgery according to package instructions.

干预措施: ChloraPrep (Drug)

结局指标

主要结局

Post-preparation skin swab

时间窗: 4 minutes post-skin preparation

bacterial culture rates following surgical skin preparation

次要结局

  • Post-operative skin swab(immediately after closure of the incision, before drape is removed from operative site)
  • Post-operative wound complications(3 months post-surgery)

研究者

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

Kurt Droll

Orthopaedic surgeon, Assistant Professor

Lakehead University

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