Propionibacterium Acnes
Conditions
Brief summary
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).
Interventions
Patients will wash with Benzoyl Peroxide 10% Bar
DRUGChlorhexidine Gluconate
Patients will wash with Chlorhexidine Gluconate
Sponsors
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
* Male subjects * Subjects scheduled for elective shoulder arthroplasty at the University of Washington Medical Center * Subjects between ages 18-89
Exclusion criteria
* Subjects who self-report very sensitive skin * Subjects who are sensitive to benzoyl peroxide * Subjects who are allergic to chlorhexidine * Subjects who had recent prior use of antibiotics (or expect to use them prior to surgery) * Subjects who had recent use of acne treatment * Subjects who are not fluent in English.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With a Positive Propionibacteria Swabs on Day of Surgery After At-Home Washes With Benzoyl Peroxide or Chlorhexidine Gluconate | Day of Surgery | 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. |
| Number of Quadrants on Culture Plate of Propionibacteria Growth - Specimens Taken Day of Surgery After At-Home Washes With Benzoyl Peroxide or Chlorhexidine Gluconate | Day of Surgery | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Hibiclens Soap Chlorhexidine Gluconate: Patients will wash with Chlorhexidine Gluconate | 25 |
| BPO Soap Benzoyl Peroxide 10% Bar: Patients will wash with Benzoyl Peroxide 10% Bar | 24 |
| Total | 49 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Change in surgical intervention | 0 | 1 |
Baseline characteristics
| Characteristic | Total | Hibiclens Soap | BPO Soap |
|---|---|---|---|
| Age, Continuous | 64.4 years STANDARD_DEVIATION 11 | 65.5 years STANDARD_DEVIATION 11.1 | 63.4 years STANDARD_DEVIATION 11.1 |
| ASA Classification I | 5 Participants | 5 Participants | 0 Participants |
| ASA Classification II | 31 Participants | 14 Participants | 17 Participants |
| ASA Classification III | 13 Participants | 6 Participants | 7 Participants |
| ASA Classification IV | 0 Participants | 0 Participants | 0 Participants |
| Body Mass Index | 29.5 kg/m^2 STANDARD_DEVIATION 6 | 28.8 kg/m^2 STANDARD_DEVIATION 6.1 | 30.3 kg/m^2 STANDARD_DEVIATION 5.9 |
| Prior Shoulder Surgery | 20 Participants | 16 Participants | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) White | 47 Participants | 25 Participants | 22 Participants |
| Sex/Gender, Customized Male | 49 Participants | 25 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 24 |
| other Total, other adverse events | 0 / 25 | 0 / 24 |
| serious Total, serious adverse events | 0 / 25 | 0 / 24 |
Outcome results
Primary
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hibiclens Soap | Number of Patients With a Positive Propionibacteria Swabs on Day of Surgery After At-Home Washes With Benzoyl Peroxide or Chlorhexidine Gluconate | Dermal Edge Positive Swab | 14 Participants |
| Hibiclens Soap | Number of Patients With a Positive Propionibacteria Swabs on Day of Surgery After At-Home Washes With Benzoyl Peroxide or Chlorhexidine Gluconate | Skin Surface Positive Swab | 25 Participants |
| BPO Soap | Number of Patients With a Positive Propionibacteria Swabs on Day of Surgery After At-Home Washes With Benzoyl Peroxide or Chlorhexidine Gluconate | Skin Surface Positive Swab | 24 Participants |
| BPO Soap | Number of Patients With a Positive Propionibacteria Swabs on Day of Surgery After At-Home Washes With Benzoyl Peroxide or Chlorhexidine Gluconate | Dermal Edge Positive Swab | 11 Participants |
Primary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hibiclens Soap | Number of Quadrants on Culture Plate of Propionibacteria Growth - Specimens Taken Day of Surgery After At-Home Washes With Benzoyl Peroxide or Chlorhexidine Gluconate | Skin Surface SpCuV | 1.6 SpCuV | Standard Deviation 1.1 |
| Hibiclens Soap | Number of Quadrants on Culture Plate of Propionibacteria Growth - Specimens Taken Day of Surgery After At-Home Washes With Benzoyl Peroxide or Chlorhexidine Gluconate | Dermal Edge SpCuV | 0.8 SpCuV | Standard Deviation 1 |
| BPO Soap | Number of Quadrants on Culture Plate of Propionibacteria Growth - Specimens Taken Day of Surgery After At-Home Washes With Benzoyl Peroxide or Chlorhexidine Gluconate | Skin Surface SpCuV | 1.5 SpCuV | Standard Deviation 1.4 |
| BPO Soap | Number of Quadrants on Culture Plate of Propionibacteria Growth - Specimens Taken Day of Surgery After At-Home Washes With Benzoyl Peroxide or Chlorhexidine Gluconate | Dermal Edge SpCuV | 0.8 SpCuV | Standard Deviation 1.4 |