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

NCT07239349 | Recruiting

• 1 other identifier: 202510005RINA
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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

Keywords

rotator cuff tear; arthroscopy; benzoyl peroxide; Cutibacterium acnes

Outcome Measures

Primary Outcomes (1)

• Suture culture results

  Right after the surgery

Study Arms (2)

Control

NO INTERVENTION

Use soap to wash shoulder before surgery

Acne face wash

EXPERIMENTAL

Use acne face wash to clean shoulder before surgery

Other: Acne face wash

Interventions

Acne face wash OTHER

Use acne face wash to clean shoulder before surgery

Acne face wash

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• rotator cuff tear
• scheduled for arthroscopic rotator cuff repair surgery

You may not qualify if:

• history of shoulder fracture
• previous shoulder surgeries
• tatoo on the shoulder

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Central Study Contacts

Chih-Kai Hong, M.D.

CONTACT

+886972651028; yayahong@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2025
• First Posted: November 20, 2025
• Study Start: November 18, 2025
• Primary Completion (Estimated): November 18, 2026
• Study Completion (Estimated): November 18, 2027
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)