Can Additional Preoperative Skin Cleaning on Face, Neck and Chest With Chlorhexidine Reduce Cutibacterium Acnes Contamination on Sutures in Arthroscopy Rotator Cuff Repair?

Arthroscopic Rotator Cuff Repair Clinical Trial

Official title:

Can Additional Preoperative Skin Cleaning on Face, Neck and Chest With Chlorhexidine Reduce Cutibacterium Acnes Contamination on Sutures in Arthroscopy Rotator Cuff Repair?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04483063
• Other study ID #: B-BR-108-052
• Status: Recruiting
• Phase: N/A
• Start date: March 23, 2020
• Est. completion date: June 30, 2022

Study information

• Verified date: July 2020
• Source: National Cheng-Kung University Hospital
• Contact: Chih-Kai Hong, MD
• Phone: 886-6-2353535
• Email: yayahong[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of our study was to investigate whether preoperative skin cleaning on face, neck, and chest with chlorhexidine could reduce suture contamination of C. acnes in arthroscopic rotator cuff repair. We hypothesized that preoperative skin cleaning on face, neck and chest with chlorhexidine can reduce C. acnes contamination on sutures in arthroscopic rotator cuff repair.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: June 30, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• primary arthroscopic rotator cuff repair

Exclusion Criteria:

• younger than 18 years

• having previous shoulder surgeries or shoulder infection episodes

• having a history of allergy to chlorhexidine

• who refused to participate

Related Conditions & MeSH terms

• Acne Vulgaris
• Arthroscopic Rotator Cuff Repair
• C. Acnes

Intervention

Drug:
• 2% chlorhexidine gluconate skin cleanser
2% chlorhexidine gluconate skin cleanser over shoulder region before shoulder surgery

Locations

Country	Name	City	State
Taiwan	National Cheng Kung University Hospital	Tainan

Sponsors (1)

Lead Sponsor	Collaborator
National Cheng-Kung University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Culture positive	Culture positive for C. acnes from the suture used in the arthroscopy	Within 2 weeks postoperatively