Cutibacterium Dermal Colonization: Implications for Total Hip Arthroplasty

January 6, 2023 updated by: Colorado Joint Replacement
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

496

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States, 80210
        • Recruiting
        • Colorado Joint Replacement
        • Principal Investigator:
          • Jason Jennings, MD
        • Sub-Investigator:
          • Douglas Dennis, MD
        • Sub-Investigator:
          • Todd Miner, MD
        • Sub-Investigator:
          • Charlie Yang, MD
        • Contact:
        • Sub-Investigator:
          • Mauricio Mejia, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Propionibacterium colinization rate on hips of healthy subjects
Time Frame: 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.
Tissues samples taken at the time of surgery will be held for 14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Colorado Joint Replacement

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 2, 2019

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

February 20, 2019

First Submitted That Met QC Criteria

February 20, 2019

First Posted (Actual)

February 21, 2019

Study Record Updates

Last Update Posted (Estimate)

January 10, 2023

Last Update Submitted That Met QC Criteria

January 6, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1378012

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

No participant data will be shared

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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