A Phase 4 interventional study of Benzoyl Peroxide 10% Bar and Chlorhexidine Gluconate in Propionibacterium Acnes, sponsored by University of Washington. Completed at 1 site in United States. Open to male participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2022-03-15.
Sponsored by University of Washington · Phase 4, Interventional, and Prevention
This is a randomized trial of benzoyl peroxide soap versus Hibiclens soap for surgical preparation. The objective is to determine whether benzoyl peroxide soap, commonly available in drug stores for over-the-counter acne treatment, is as or more effective than the standard surgical preoperative soap, Hibiclens soap (chlorhexidine gluconate), in reducing loads of Propionibacteria (Propi) on or under the skin of patients prior to shoulder arthroplasty (joint replacement).
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Exclusion Criteria:
Drug: Chlorhexidine Gluconate
Drug: Benzoyl Peroxide 10% Bar
Patients will wash with Benzoyl Peroxide 10% Bar
Patients will wash with Chlorhexidine Gluconate
Number of Patients With a Positive Propionibacteria Swabs on Day of Surgery After At-Home Washes With Benzoyl Peroxide or Chlorhexidine Gluconate
Patients were randomly assigned to use either benzoyl peroxide soap or Hibiclens soap (chlorhexidine gluconate) at home the night before and the morning of surgery. On the day of surgery the patients' skin and incisions were swabbed in the operating room prior to shoulder arthroplasty. Specimens were held for 21 days.
Time frame: Day of Surgery
Number of Quadrants on Culture Plate of Propionibacteria Growth - Specimens Taken Day of Surgery After At-Home Washes With Benzoyl Peroxide or Chlorhexidine Gluconate
This outcome measures the load of Propionibacteria on the skin and incision of participants in the operating room prior to shoulder arthroplasty when patients were randomly assigned to use either benzoyl peroxide soap or Hibiclens soap (chlorhexidine gluconate) at home the night before and the morning of surgery. The Propionibacteria load was quantified based on the growth of bacteria on the agar plate using a quadrant system. Quantitative specimen Propionibacteria values (SpCuVs) were assigned as following: "no growth"= 0, "broth only"= 0.1, "one colony only"= 0.1, and 1 quadrant growth = 1, 2 quadrant growth = 2, 3 quadrant growth = 3, and 4 quadrant growth = 4. Samples were taken on the day of surgery and the cultures were held for 21 days.
Time frame: Day of Surgery
| Milestone | Hibiclens Soap | BPO Soap |
|---|---|---|
| Started | 25 | 25 |
| Completed | 25 | 24 |
| Not completed | 0 | 1 |
| Withdrew: Change in surgical intervention | 0 | 1 |
Patients were randomly assigned to use either benzoyl peroxide soap or Hibiclens soap (chlorhexidine gluconate) at home the night before and the morning of surgery. On the day of surgery the patients' skin and incisions were swabbed in the operating room prior to shoulder arthroplasty. Specimens were held for 21 days.
| Participants | Hibiclens Soap | BPO Soap |
|---|---|---|
| Skin Surface Positive Swab | 25 | 24 |
| Dermal Edge Positive Swab | 14 | 11 |
This outcome measures the load of Propionibacteria on the skin and incision of participants in the operating room prior to shoulder arthroplasty when patients were randomly assigned to use either benzoyl peroxide soap or Hibiclens soap (chlorhexidine gluconate) at home the night before and the morning of surgery. The Propionibacteria load was quantified based on the growth of bacteria on the agar plate using a quadrant system. Quantitative specimen Propionibacteria values (SpCuVs) were assigned as following: "no growth"= 0, "broth only"= 0.1, "one colony only"= 0.1, and 1 quadrant growth = 1, 2 quadrant growth = 2, 3 quadrant growth = 3, and 4 quadrant growth = 4. Samples were taken on the day of surgery and the cultures were held for 21 days.
| SpCuV | Hibiclens Soap | BPO Soap |
|---|---|---|
| Skin Surface SpCuV | 1.6 ± 1.1 | 1.5 ± 1.4 |
| Dermal Edge SpCuV | 0.8 ± 1.0 | 0.8 ± 1.4 |
Collected over Day of surgery. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Hibiclens Soap | 0/25 (0%) | 0/25 (0%) | 0/25 (0%) |
| BPO Soap | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) |
| Age, Continuous(years) | Hibiclens Soap | BPO Soap | Total |
|---|---|---|---|
| Mean | 65.5 ± 11.1 | 63.4 ± 11.1 | 64.4 ± 11.0 |
| Sex/Gender, Customized(Participants) | Hibiclens Soap | BPO Soap | Total |
|---|---|---|---|
| Male | 25 | 24 | 49 |
| Race (NIH/OMB)(Participants) | Hibiclens Soap | BPO Soap | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 25 | 22 | 47 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 2 | 2 |
| Body Mass Index(kg/m^2) | Hibiclens Soap | BPO Soap | Total |
|---|---|---|---|
| Median | 28.8 ± 6.1 | 30.3 ± 5.9 | 29.5 ± 6.0 |
| Prior Shoulder Surgery(Participants) | Hibiclens Soap | BPO Soap | Total |
|---|---|---|---|
| Count of participants | 16 | 4 | 20 |
| ASA Classification(Participants) | Hibiclens Soap | BPO Soap | Total |
|---|---|---|---|
| I | 5 | 0 | 5 |
| II | 14 | 17 | 31 |
| III | 6 | 7 | 13 |
| IV | 0 | 0 | 0 |
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University of Washington