Recruiting

Observational Study

Sponsor:

Colorado Joint Replacement

Code:

NCT03849885

Conditions

Degenerative Osteoarthritis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Benzoyl peroxide gel

Study Details

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.

Conditions

Degenerative Osteoarthritis

Study ID

NCT03849885

Start date

Feb 2, 2019

Status verified date

Jan, 2023

Completion date

Dec 31, 2024

Anticipated

Primary completion date

Dec 31, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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

Enrollment

496 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

no intervention: Standard Skin Prep

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: Experimental Skin Prep with BPO

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.

Interventions

Benzoyl peroxide gel

Skin prep with Chlorohexidine wipes and BPO.

Primary outcome measure

  • Propionibacterium colinization rate on hips of healthy subjects [ Time Frame: Tissues samples taken at the time of surgery will be held for 14 days ]

Central Contacts and Locations

Central contacts

Roseann Johnson, BS CCRP

303-260-2940roseannjohnson@centura.org

Locations

Colorado Joint Replacement

Recruiting

Denver, Colorado, United States, 80210

Contacts

Roseann Johnson

303-260-2940RoseannJohnson@centura.org

Principal Investigator:

Jason Jennings, MD

More Information

Sponsor

Colorado Joint Replacement

Last update posted

Jan 10, 2023

Last verified

Jan, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Colorado Joint Replacement on 2023-01-10.