- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07239349
Acne Face Wash for Reducing the Contamination Rate in Arthroscopic Rotator Cuff Repair Surgery
November 16, 2025 updated by: National Taiwan University Hospital
Investigating Whether Preoperative Use of Acne Face Wash for Cleansing the Face, Neck, and Chest Helps Reduce the Contamination Rate of Cutibacterium Acnes in Arthroscopic Rotator Cuff Repair Surgery
Previous studies have shown that even when following standard sterilization protocols, the positive culture rate of Cutibacterium acnes can still be as high as 30%.
In recent years, several studies have reported that preoperative skin preparation of the shoulder, such as applying benzoyl peroxide (BPO) to the skin, can effectively reduce the cutaneous bacterial load of C. acnes and even decrease its incidence in the shoulder joint or surgical sutures after surgery.
However, most of the existing studies have focused on arthroplasty, and robust evidence regarding contamination in rotator cuff surgery remains lacking.
Therefore, this study aims to investigate whether preoperative skin preparation with a 10% BPO acne cleanser can effectively reduce contamination in rotator cuff surgery.
The findings will help guide future clinical practice in preoperative preparation.
This study will adopt a prospective randomized design.
Patients will be randomly assigned (using a random number table) into two groups: the control group and the BPO cleanser group.
All patients will receive instructions on preoperative skin cleansing.
Patients in the control group will follow the current routine practice in our institution, cleansing the surgical site (shoulder) with soap or body wash.
Patients in the BPO group, in addition to routine preoperative instructions, will receive specific guidance on cleansing the shoulder and surrounding skin.
They will be provided with a 10% BPO acne cleanser and instructed to use it on the shoulder and surrounding area during bathing the day before surgery.
After surgical disinfection, skin samples will be collected for bacterial culture.
In addition, a segment of surgical suture will be obtained postoperatively for bacterial culture.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
150
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Chih-Kai Hong, M.D.
- Phone Number: +886972651028
- Email: yayahong@gmail.com
Study Locations
-
-
-
Taipei, Taiwan, 100
- Recruiting
- National Taiwan University Hospital
-
Contact:
- Chih-Kai Hong
- Phone Number: +886972651028
- Email: yayahong@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- rotator cuff tear
- scheduled for arthroscopic rotator cuff repair surgery
Exclusion Criteria:
- history of shoulder fracture
- previous shoulder surgeries
- tatoo on the shoulder
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
Use soap to wash shoulder before surgery
|
|
|
Experimental: Acne face wash
Use acne face wash to clean shoulder before surgery
|
Use acne face wash to clean shoulder before surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Suture culture results
Time Frame: Right after the surgery
|
Right after the surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
November 18, 2025
Primary Completion (Estimated)
November 18, 2026
Study Completion (Estimated)
November 18, 2027
Study Registration Dates
First Submitted
November 16, 2025
First Submitted That Met QC Criteria
November 16, 2025
First Posted (Actual)
November 20, 2025
Study Record Updates
Last Update Posted (Actual)
November 20, 2025
Last Update Submitted That Met QC Criteria
November 16, 2025
Last Verified
November 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202510005RINA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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