Cutibacterium Dermal Colonization: Implications for Total Hip Arthroplasty

Phase 4

Recruiting

• Conditions: Degenerative Osteoarthritis
• Interventions: Drug: Benzoyl peroxide gel

• Registration Number: NCT03849885
• Lead Sponsor: Colorado Joint Replacement

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.

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 Timeline

• Study Start: 2019-02-02
• Study First Submitted: 2019-02-20
• Study First Submitted QC: 2019-02-20
• Study First Posted: 2019-02-21
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-06
• Last Update Posted: 2023-01-10
• Primary Completion: 2023-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 496

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Skin Prep with BPO	Benzoyl peroxide gel	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Colorado Joint Replacement; 🇺🇸 Denver, Colorado, United States