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Efficacy of Surgical Skin Preparation Solutions in Hip Arthroplasty Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03393819
Recruitment Status : Completed
First Posted : January 9, 2018
Last Update Posted : July 1, 2019
Sponsor:
Collaborator:
Thunder Bay Regional Health Sciences Centre
Information provided by (Responsible Party):
Kurt Droll, Lakehead University

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.

Condition or disease Intervention/treatment Phase
Arthroplasty, Hip Replacement Infection, Postoperative Wound Drug: DuraPrep Drug: ChloraPrep Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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).
Primary Purpose: Treatment
Official Title: Efficacy of Surgical Skin Preparation Solutions in Hip Arthroplasty Surgery
Actual Study Start Date : October 29, 2014
Actual Primary Completion Date : January 7, 2016
Actual Study Completion Date : April 6, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Duraprep Surgical Solution
Surgical site (hip) is prepared with Duraprep (iodine-alcohol) prior to surgery according to package instructions.
Drug: DuraPrep
DuraPrep surgical solution
Other Name: Iodine Povacrylex and Isopropyl Alcohol

Experimental: Chloraprep Surgical Solution
Surgical site (hip) is prepared with Chloraprep (chlorhexidine-alcohol) prior to surgery according to package instructions.
Drug: ChloraPrep
ChloraPrep surgical solution
Other Name: chlorhexidine-alcohol




Primary Outcome Measures :
  1. Post-preparation skin swab [ Time Frame: 4 minutes post-skin preparation ]
    bacterial culture rates following surgical skin preparation


Secondary Outcome Measures :
  1. Post-operative skin swab [ Time Frame: immediately after closure of the incision, before drape is removed from operative site ]
    bacterial culture rates following surgery

  2. Post-operative wound complications [ Time Frame: 3 months post-surgery ]
    wound complications at follow-up



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03393819


Sponsors and Collaborators
Lakehead University
Thunder Bay Regional Health Sciences Centre
Investigators
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Principal Investigator: Kurt Droll, MD TBRHSC
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Responsible Party: Kurt Droll, Orthopaedic surgeon, Assistant Professor, Lakehead University
ClinicalTrials.gov Identifier: NCT03393819    
Other Study ID Numbers: RP-002-01072013
First Posted: January 9, 2018    Key Record Dates
Last Update Posted: July 1, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kurt Droll, Lakehead University:
antimicrobial skin solution
skin preparation
Additional relevant MeSH terms:
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Surgical Wound Infection
Wound Infection
Infections
Postoperative Complications
Pathologic Processes
Ethanol
Chlorhexidine
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Disinfectants