MedDataX Logo

Trial Outcomes & Findings for BPO vs Hibiclens Soap for Surgical Preparation (NCT NCT04021524)

NCT ID: NCT04021524

Last Updated: 2022-03-15

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

50 participants

Primary outcome timeframe

Day of Surgery

Results posted on

2022-03-15

Participant Flow

Participant milestones

Participant milestones
Measure
Hibiclens Soap
Chlorhexidine Gluconate: Patients will wash with Chlorhexidine Gluconate
BPO Soap
Benzoyl Peroxide 10% Bar: Patients will wash with Benzoyl Peroxide 10% Bar
Overall Study
STARTED
25
25
Overall Study
COMPLETED
25
24
Overall Study
NOT COMPLETED
0
1

Reasons for withdrawal

Reasons for withdrawal
Measure
Hibiclens Soap
Chlorhexidine Gluconate: Patients will wash with Chlorhexidine Gluconate
BPO Soap
Benzoyl Peroxide 10% Bar: Patients will wash with Benzoyl Peroxide 10% Bar
Overall Study
Change in surgical intervention
0
1

Baseline Characteristics

BPO vs Hibiclens Soap for Surgical Preparation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Hibiclens Soap
n=25 Participants
Chlorhexidine Gluconate: Patients will wash with Chlorhexidine Gluconate
BPO Soap
n=24 Participants
Benzoyl Peroxide 10% Bar: Patients will wash with Benzoyl Peroxide 10% Bar
Total
n=49 Participants
Total of all reporting groups
Age, Continuous
65.5 years
STANDARD_DEVIATION 11.1 • n=5 Participants
63.4 years
STANDARD_DEVIATION 11.1 • n=7 Participants
64.4 years
STANDARD_DEVIATION 11.0 • n=5 Participants
Sex/Gender, Customized
Male
25 Participants
n=5 Participants
24 Participants
n=7 Participants
49 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
White
25 Participants
n=5 Participants
22 Participants
n=7 Participants
47 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
2 Participants
n=7 Participants
2 Participants
n=5 Participants
Body Mass Index
28.8 kg/m^2
STANDARD_DEVIATION 6.1 • n=5 Participants
30.3 kg/m^2
STANDARD_DEVIATION 5.9 • n=7 Participants
29.5 kg/m^2
STANDARD_DEVIATION 6.0 • n=5 Participants
Prior Shoulder Surgery
16 Participants
n=5 Participants
4 Participants
n=7 Participants
20 Participants
n=5 Participants
ASA Classification
I
5 Participants
n=5 Participants
0 Participants
n=7 Participants
5 Participants
n=5 Participants
ASA Classification
II
14 Participants
n=5 Participants
17 Participants
n=7 Participants
31 Participants
n=5 Participants
ASA Classification
III
6 Participants
n=5 Participants
7 Participants
n=7 Participants
13 Participants
n=5 Participants
ASA Classification
IV
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Hibiclens Soap
n=25 Participants
Chlorhexidine Gluconate: Patients will wash with Chlorhexidine Gluconate
BPO Soap
n=24 Participants
Benzoyl Peroxide 10% Bar: Patients will wash with Benzoyl Peroxide 10% Bar
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
24 Participants
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
11 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Hibiclens Soap
n=25 Participants
Chlorhexidine Gluconate: Patients will wash with Chlorhexidine Gluconate
BPO Soap
n=24 Participants
Benzoyl Peroxide 10% Bar: Patients will wash with Benzoyl Peroxide 10% Bar
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
1.5 SpCuV
Standard Deviation 1.4
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 1.0
0.8 SpCuV
Standard Deviation 1.4

Adverse Events

Hibiclens Soap

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

BPO Soap

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jason E. Hsu

University of Washington

Phone: (206) 543-3690

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place