Efficacy of Surgical Skin Preparation Solutions in Hip Arthroplasty Surgery
Primary Purpose
Arthroplasty, Hip Replacement, Infection, Postoperative Wound
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
DuraPrep
ChloraPrep
Sponsored by
About this trial
This is an interventional treatment trial for Arthroplasty, Hip Replacement focused on measuring antimicrobial skin solution, skin preparation
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Duraprep Surgical Solution
Chloraprep Surgical Solution
Arm Description
Surgical site (hip) is prepared with Duraprep (iodine-alcohol) prior to surgery according to package instructions.
Surgical site (hip) is prepared with Chloraprep (chlorhexidine-alcohol) prior to surgery according to package instructions.
Outcomes
Primary Outcome Measures
Post-preparation skin swab
bacterial culture rates following surgical skin preparation
Secondary Outcome Measures
Post-operative skin swab
bacterial culture rates following surgery
Post-operative wound complications
wound complications at follow-up
Full Information
NCT ID
NCT03393819
First Posted
January 3, 2018
Last Updated
June 28, 2019
Sponsor
Lakehead University
Collaborators
Thunder Bay Regional Health Sciences Centre
1. Study Identification
Unique Protocol Identification Number
NCT03393819
Brief Title
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
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
October 29, 2014 (Actual)
Primary Completion Date
January 7, 2016 (Actual)
Study Completion Date
April 6, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lakehead University
Collaborators
Thunder Bay Regional Health Sciences Centre
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthroplasty, Hip Replacement, Infection, Postoperative Wound
Keywords
antimicrobial skin solution, skin preparation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
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).
Allocation
Randomized
Enrollment
105 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Duraprep Surgical Solution
Arm Type
Experimental
Arm Description
Surgical site (hip) is prepared with Duraprep (iodine-alcohol) prior to surgery according to package instructions.
Arm Title
Chloraprep Surgical Solution
Arm Type
Experimental
Arm Description
Surgical site (hip) is prepared with Chloraprep (chlorhexidine-alcohol) prior to surgery according to package instructions.
Intervention Type
Drug
Intervention Name(s)
DuraPrep
Other Intervention Name(s)
Iodine Povacrylex and Isopropyl Alcohol
Intervention Description
DuraPrep surgical solution
Intervention Type
Drug
Intervention Name(s)
ChloraPrep
Other Intervention Name(s)
chlorhexidine-alcohol
Intervention Description
ChloraPrep surgical solution
Primary Outcome Measure Information:
Title
Post-preparation skin swab
Description
bacterial culture rates following surgical skin preparation
Time Frame
4 minutes post-skin preparation
Secondary Outcome Measure Information:
Title
Post-operative skin swab
Description
bacterial culture rates following surgery
Time Frame
immediately after closure of the incision, before drape is removed from operative site
Title
Post-operative wound complications
Description
wound complications at follow-up
Time Frame
3 months post-surgery
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kurt Droll, MD
Organizational Affiliation
TBRHSC
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy of Surgical Skin Preparation Solutions in Hip Arthroplasty Surgery
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