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Completed

NCT Number: NCT03393819

Efficacy of Surgical Skin Preparation Solutions in 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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

DuraPrep

Drug

DuraPrep surgical solution

Other names: Iodine Povacrylex and Isopropyl Alcohol

Chloraprep

Drug

ChloraPrep surgical solution

Other names: chlorhexidine-alcohol

Primary outcomes

  1. Post-preparation skin swab

    Time frame: 4 minutes post-skin preparation

    bacterial culture rates following surgical skin preparation

Secondary outcomes

  1. Post-operative skin swab

    Time frame: immediately after closure of the incision, before drape is removed from operative site

    bacterial culture rates following surgery

  2. Post-operative wound complications

    Time frame: 3 months post-surgery

    wound complications at follow-up

Sponsors and collaborators

Lead sponsor

Lakehead University

Other

Collaborators

  • Thunder Bay Regional Health Sciences Centre

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jan 9, 2018
Registry last updated
Jul 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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