Official Title

Cutibacterium Dermal Colonization: Implications for Total Hip Arthroplasty
  • Phase

    Phase 4
  • Study Type

    Interventional
  • Status

    Recruiting
  • Study Participants

    496
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.
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 Started
Feb 02
2019
Primary Completion
Dec 31
2023
Anticipated
Study Completion
Dec 31
2024
Anticipated
Last Update
Jan 10
2023

Drug Benzoyl peroxide gel

Skin prep with Chlorohexidine wipes and BPO.

  • Other names: Acne Medication

Standard Skin Prep No Intervention

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 Skin Prep with BPO Experimental

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.

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)
No Results Posted