NCT03849885

Cutibacterium Dermal Colonization: Implications for Total Hip Arthroplasty

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 496 (estimated)
• Sponsor: Colorado Joint Replacement · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

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.

Conditions

• Degenerative Osteoarthritis

Interventions

Type	Name	Description
DRUG	Benzoyl peroxide gel	Skin prep with Chlorohexidine wipes and BPO.

Timeline

• Start date: 2019-02-02
• Primary completion: 2023-12-31
• Completion: 2024-12-31
• First posted: 2019-02-21
• Last updated: 2023-01-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study