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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
Lakehead University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthroplasty, Hip Replacement focused on measuring antimicrobial skin solution, skin preparation

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

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

    First Posted
    January 3, 2018
    Last Updated
    June 28, 2019
    Sponsor
    Lakehead University
    Collaborators
    Thunder Bay Regional Health Sciences Centre
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    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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