Efficacy of Surgical Skin Preparation Solutions in Hip Arthroplasty Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-29

Study Completion Date

2016-04-06

Brief Summary

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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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Detailed Description

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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.

Conditions

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Arthroplasty, Hip Replacement Infection, Postoperative Wound

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

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).

Study Groups

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Duraprep Surgical Solution

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

Group Type EXPERIMENTAL

DuraPrep

Intervention Type DRUG

DuraPrep surgical solution

Chloraprep Surgical Solution

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

Group Type EXPERIMENTAL

ChloraPrep

Intervention Type DRUG

ChloraPrep surgical solution

Interventions

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DuraPrep

DuraPrep surgical solution

Intervention Type DRUG

ChloraPrep

ChloraPrep surgical solution

Intervention Type DRUG

Other Intervention Names

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Iodine Povacrylex and Isopropyl Alcohol chlorhexidine-alcohol

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No