Acne Face Wash for Reducing the Contamination Rate in Arthroscopic Rotator Cuff Repair Surgery

NCT ID: NCT07239349

Last Updated: 2025-11-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-18
• Study Completion Date: 2027-11-18

Brief Summary

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.

Conditions

Rotator Cuff Tears of the Shoulder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Control

Use soap to wash shoulder before surgery

Group Type: NO_INTERVENTION

No interventions assigned to this group

Acne face wash

Use acne face wash to clean shoulder before surgery

Group Type: EXPERIMENTAL

Acne face wash

Intervention Type: OTHER

Use acne face wash to clean shoulder before surgery

Interventions

Acne face wash

Use acne face wash to clean shoulder before surgery

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

National Taiwan University Hospital

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Chih-Kai Hong, M.D.

Role: CONTACT

yayahong@gmail.com

+886972651028

Facility Contacts

Chih-Kai Hong

Role: primary

yayahong@gmail.com

+886972651028

Other Identifiers

202510005RINA

Identifier Type: -

Identifier Source: org_study_id