Clinical trial NCT03849885: Cutibacterium Dermal Colonization: Implications for Total Hip Arthroplasty
Official title: Cutibacterium Dermal Colonization: Implications for Total Hip Arthroplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Degenerative Osteoarthritis
Lead sponsor: Colorado Joint Replacement
Sponsor class: OTHER
First posted: 2019-02-21
Enrollment: 496
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group 1 - 4 %Chlorohexidine Wipe Group 2 - 4 % Chlorohexidine Wipe with 5% benzoyl peroxide (BPO) application
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Propionibacterium colinization rate on hips of healthy subjects
timeFrame: Tissues samples taken at the time of surgery will be held for 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: Colorado Joint Replacement
state: Colorado
Study officials:
affiliation: Colorado Joint Replacement
name: Jason M Jennings, MD DPT
role: PRINCIPAL_INVESTIGATOR
References:
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