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Cutibacterium Dermal Colonization: Implications for Total Hip Arthroplasty

Cutibacterium Dermal Colonization: Implications for Total Hip Arthroplasty

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03849885
Enrollment
496
Registered
2019-02-21
Start date
2019-02-02
Completion date
2024-12-31
Last updated
2023-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Degenerative Osteoarthritis

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.

Interventions

Skin prep with Chlorohexidine wipes and BPO.

Sponsors

Colorado Joint Replacement
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

Group 1 - 4 %Chlorohexidine Wipe Group 2 - 4 % Chlorohexidine Wipe with 5% benzoyl peroxide (BPO) application

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
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)

Design outcomes

Primary

MeasureTime frameDescription
Propionibacterium colinization rate on hips of healthy subjectsTissues samples taken at the time of surgery will be held for 14 daysThe 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.

Countries

United States

Contacts

Primary ContactRoseann Johnson, BS CCRP
roseannjohnson@centura.org303-260-2940

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026