Efficacy of Surgical Skin Preparation Solutions in Hip Arthroplasty Surgery

Lakehead University

Status: Completed

Conditions: Arthroplasty, Hip Replacement; Infection, Postoperative Wound

Treatments: Drug: ChloraPrep; Drug: DuraPrep

Study type: Interventional

Funder types: Other

Identifiers

NCT03393819

RP-002-01072013

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 105 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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105 participants in 2 patient groups

Duraprep Surgical Solution

Experimental group

Description:

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

Treatment:

Drug: DuraPrep

Chloraprep Surgical Solution

Experimental group

Description:

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

Treatment:

Drug: ChloraPrep