Clinical trial NCT03393819: Efficacy of Surgical Skin Preparation Solutions in Hip Arthroplasty Surgery
Official title: Efficacy of Surgical Skin Preparation Solutions in Hip Arthroplasty Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthroplasty, Hip Replacement
Infection, Postoperative Wound
Keywords: antimicrobial skin solution
skin preparation
Lead sponsor: Lakehead University
Sponsor class: OTHER
Collaborators: name: Thunder Bay Regional Health Sciences Centre
First posted: 2018-01-09
Enrollment: 105
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Post-preparation skin swab
timeFrame: 4 minutes post-skin preparation
Secondary outcomes:
measure: Post-operative skin swab
timeFrame: immediately after closure of the incision, before drape is removed from operative site
measure: Post-operative wound complications
timeFrame: 3 months post-surgery
Other outcomes:
Locations:
Study officials:
affiliation: TBRHSC
name: Kurt Droll, MD
role: PRINCIPAL_INVESTIGATOR
References: