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Efficacy of Surgical Preparation Solutions in Knee Surgery

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ClinicalTrials.gov Identifier: NCT01857349
Recruitment Status : Enrolling by invitation
First Posted : May 20, 2013
Last Update Posted : November 22, 2019
Sponsor:
Information provided by (Responsible Party):
Texas Tech University Health Sciences Center

Brief Summary:
The goal of this study is to determine the superiority of surgical scrub preparations in total knee arthroplasty based on the bacterial counts present on the skin surface and in the deep joint tissues. These counts will be obtained by culturing the skin prior to any scrub preparation, post preparation after the application of the sterile drapes, deep joint tissue sample prior to wound closure, and immediately post wound closure. This study will provide an assessment of the management of sterility by comparing quantitative and qualitative cultures immediately after surgical scrub preparation and the maintenance of sterility throughout the procedure. This study will enhance prior research efforts by contributing quantitative bacterial load and bacterial load within the surgical wound at closure.

Condition or disease Intervention/treatment Phase
Arthroplasty, Replacement Other: Chlora Prep Other: Dura Prep Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Efficacy of Surgical Preparation Solutions in Knee Surgery
Study Start Date : April 2013
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Arm Intervention/treatment
Active Comparator: Chlora Prep
Food and Drug Administration (FDA)-approved, surgical skin preparation solution: ChloraPrep (2% chlorhexidine gluconate and 70% isopropyl alcohol; Enturia, El Paso, Texas)
Other: Chlora Prep
Surgical Scrub skin preparation
Other Name: 2% chlorhexidine gluconate and 70% isopropyl alcohol

Active Comparator: Dura Prep
Food and Drug Administration (FDA)-approved, surgical skin preparation solution:DuraPrep (0.7% available iodine and 74% isopropyl alcohol; 3MHealthcare, St. Paul, Minnesota).
Other: Dura Prep
Surgical Scrub skin preparation
Other Name: 0.7% available iodine and 74% isopropyl alcohol




Primary Outcome Measures :
  1. Quantitative and qualitative bacterial load [ Time Frame: At time of surgery ]
    Quantitative and qualitative bacterial load will be obtained by skin cultures and one deep joint tissue culture from the joint space prior to wound closure in primary and revision total knee surgeries.


Secondary Outcome Measures :
  1. Rate of surgical site infections [ Time Frame: at time of surgery ]
    Rate of surgical site infections in chloraprep and duraprep groups.



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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • >18 years old and less than 89
  • Undergoing primary total knee arthroplasty
  • Not undergoing surgical intervention for infection

Exclusion Criteria:

Injury due to trauma

  • Open wound at the incision site determined by pre-op history and physical
  • Abrasion in the vicinity of the planned incision site determined by pre-op history and physical
  • Active infection at or near the surgical incision site determined by pre-op history and physical
  • Active infection somewhere else in the body determined by pre-op labs and history and physical
  • Prior history of surgical infection or bacteremia determined by pre-op history and physical
  • History of rheumatoid arthritis determined by pre-op history and physical
  • History of autoimmune disorder determined by pre-op history and physical
  • Immunosuppressed patient determined by pre-op history and physical
  • Known allergy to iodine, isopropyl alcohol or Chlorhexidine

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): NCT01857349


Locations
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United States, Texas
Texas Tech University Health Science Center Orthopaedic Surgery
Lubbock, Texas, United States, 79430
Sponsors and Collaborators
Texas Tech University Health Sciences Center
Investigators
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Principal Investigator: George W Brindley, MD Texas Tech University Health Science Center Orthopaedic Surgery
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Responsible Party: Texas Tech University Health Sciences Center
ClinicalTrials.gov Identifier: NCT01857349    
Other Study ID Numbers: L13-016
First Posted: May 20, 2013    Key Record Dates
Last Update Posted: November 22, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Texas Tech University Health Sciences Center:
Efficacy
surgical scrubs
Total Knee Arthroplasty
Additional relevant MeSH terms:
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Ethanol
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Disinfectants
Dermatologic Agents