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Cutibacterium Dermal Colonization: Implications for Total Hip Arthroplasty

Primary Purpose

Degenerative Osteoarthritis

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Benzoyl peroxide gel
Sponsored by
Colorado Joint Replacement
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Degenerative Osteoarthritis

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Colorado Joint ReplacementRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard Skin Prep

Experimental Skin Prep with BPO

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Propionibacterium colinization rate on hips of healthy subjects
The 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.

Secondary Outcome Measures

Full Information

First Posted
February 20, 2019
Last Updated
January 6, 2023
Sponsor
Colorado Joint Replacement
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1. Study Identification

Unique Protocol Identification Number
NCT03849885
Brief Title
Cutibacterium Dermal Colonization: Implications for Total Hip Arthroplasty
Official Title
Cutibacterium Dermal Colonization: Implications for Total Hip Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 2, 2019 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Colorado Joint Replacement

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Degenerative Osteoarthritis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Group 1 - 4 %Chlorohexidine Wipe Group 2 - 4 % Chlorohexidine Wipe with 5% benzoyl peroxide (BPO) application
Masking
None (Open Label)
Allocation
Randomized
Enrollment
496 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard Skin Prep
Arm Type
No Intervention
Arm Description
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.
Arm Title
Experimental Skin Prep with BPO
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Benzoyl peroxide gel
Other Intervention Name(s)
Acne Medication
Intervention Description
Skin prep with Chlorohexidine wipes and BPO.
Primary Outcome Measure Information:
Title
Propionibacterium colinization rate on hips of healthy subjects
Description
The 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.
Time Frame
Tissues samples taken at the time of surgery will be held for 14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Roseann Johnson, BS CCRP
Phone
303-260-2940
Email
roseannjohnson@centura.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason M Jennings, MD DPT
Organizational Affiliation
Colorado Joint Replacement
Official's Role
Principal Investigator
Facility Information:
Facility Name
Colorado Joint Replacement
City
Denver
State/Province
Colorado
ZIP/Postal Code
80210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roseann Johnson
Phone
303-260-2940
Email
RoseannJohnson@centura.org
First Name & Middle Initial & Last Name & Degree
Jason Jennings, MD
First Name & Middle Initial & Last Name & Degree
Douglas Dennis, MD
First Name & Middle Initial & Last Name & Degree
Todd Miner, MD
First Name & Middle Initial & Last Name & Degree
Charlie Yang, MD
First Name & Middle Initial & Last Name & Degree
Mauricio Mejia, MD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No participant data will be shared
Citations:
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Cutibacterium Dermal Colonization: Implications for Total Hip Arthroplasty

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