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Cutibacterium Dermal Colonization: Implications for Total Hip Arthroplasty

Sponsor
Colorado Joint Replacement (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03849885
Collaborator
(none)
496
Enrollment
1
Location
2
Arms
46.9
Anticipated Duration (Months)
10.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is being done to investigate the colonization rate(growth rate) of a particular type of low-virulence (does not typically cause infection) bacterium called Propionibacterium, more specifically P acnes, the same bacterium that is responsible for the majority of acne. Information affecting hip surgery is currently unknown.

Condition or Disease Intervention/Treatment Phase
  • Drug: Benzoyl peroxide gel
 Phase 4

Detailed Description

This study is being done to investigate the colonization rate(growth rate) of a particular type of low-virulence (does not typically cause infection) bacterium called Propionibacterium. The most common bacterium of this family is P acnes, the same bacterium that is responsible for the majority of acne. There is increasing evidence that infection with P acnes and other Propionibacterium is a significant source of failure following certain orthopaedic shoulder procedures. However, information affecting hip surgery is currently unknown. Our personal experience leads us to believe that the numbers are actually quite high, since we are seeing an increased rate of Propionibacterium infection of hip replacement in the community. However, this type of study has never been done before, and therefore we simply do not know an accurate estimate for the average hip replacement patient's risk for Propionibacterium infection following hip replacement.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
496 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Group 1 - 4 %Chlorohexidine Wipe Group 2 - 4 % Chlorohexidine Wipe with 5% benzoyl peroxide (BPO) applicationGroup 1 - 4 %Chlorohexidine Wipe Group 2 - 4 % Chlorohexidine Wipe with 5% benzoyl peroxide (BPO) application
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Cutibacterium Dermal Colonization: Implications for Total Hip Arthroplasty
Actual Study Start Date :
Feb 2, 2019
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Standard Skin Prep

Patients will undergo a skin cleansing protocols using 4% Chlorhexidine gluconate (CHG) cloths. After the skin prep, three 3-mm punch (Acu-Punch, Acuderm, Fort Lauderdale, FL) skin biopsies will performed for both an anterior-based hypothetical incision, and for a more lateral/posterior incision, for a total of 6 biopsies taken per subject.
Experimental: Experimental Skin Prep with BPO

Patients will undergo a skin cleansing protocols using 4% Chlorhexidine gluconate (CHG) cloths. Following the CHG wipes, patients will be prepped with 5% BPO gel applied directly to the biopsy site. After the skin prep, three 3-mm punch (Acu-Punch, Acuderm, Fort Lauderdale, FL) skin biopsies will performed for both an anterior-based hypothetical incision, and for a more lateral/posterior incision, for a total of 6 biopsies taken per subject.

Drug: Benzoyl peroxide gel
Skin prep with Chlorohexidine wipes and BPO.
Other Names:
  • Acne Medication

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Propionibacterium colinization rate on hips of healthy subjects [Tissues samples taken at the time of surgery will be held for 14 days]

      The rate at which Propionibacterium could be isolated from the skin of healthy subjects at locations corresponding to both the direct anterior and posterior surgical approaches with and without intervention.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Patients who are 18 to 79 85 years of age

    • CJR primary joint arthroplasty patients who are receiving care at Porter Adventist Hospital

    • CJR established primary knee or hip arthroplasty patients with a native hip joint (no replacement on the biopsy side) who volunteers as a research participant.

    • CJR patients without a previous arthroplasty procedure who have established care with our practice.

    Exclusion Criteria:

    • Previous history of hip infection

    • Current antibiotic use or antibiotic use within the past week

    • Previous history of Cutibacterium joint infection

    • Current immunodeficiency disease or disorder

    • Patients with active psoriatic disease or other focal inflammation over the hip

    • Previous total hip arthroplasty (bilateral for the case of TKA patients and healthy volunteers, contralateral for THA patients)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Colorado Joint Replacement Denver Colorado United States 80210

    Sponsors and Collaborators

    • Colorado Joint Replacement

    Investigators

    • Principal Investigator: Jason M Jennings, MD DPT, Colorado Joint Replacement

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Colorado Joint Replacement
    ClinicalTrials.gov Identifier:
    NCT03849885
    Other Study ID Numbers:
    • 1378012
    First Posted:
    Feb 21, 2019
    Last Update Posted:
    Aug 9, 2021
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Additional relevant MeSH terms:
    Osteoarthritis
    Benzoyl Peroxide

    Study Results

    No Results Posted as of Aug 9, 2021