Efficacy of Surgical Skin Preparation Solutions in Hip Arthroplasty Surgery
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Duraprep Surgical Solution
Surgical site (hip) is prepared with Duraprep (iodine-alcohol) prior to surgery according to package instructions.
|
DuraPrep surgical solution
Other Names:
|
|
EXPERIMENTAL: Chloraprep Surgical Solution
Surgical site (hip) is prepared with Chloraprep (chlorhexidine-alcohol) prior to surgery according to package instructions.
|
ChloraPrep surgical solution
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Post-preparation skin swab
Time Frame: 4 minutes post-skin preparation
|
bacterial culture rates following surgical skin preparation
|
4 minutes post-skin preparation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Post-operative skin swab
Time Frame: immediately after closure of the incision, before drape is removed from operative site
|
bacterial culture rates following surgery
|
immediately after closure of the incision, before drape is removed from operative site
|
|
Post-operative wound complications
Time Frame: 3 months post-surgery
|
wound complications at follow-up
|
3 months post-surgery
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Kurt Droll, MD, TBRHSC
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RP-002-01072013
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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