Back to resultsCan Additional Preoperative Skin Cleaning on Face, Neck and Chest With Chlorhexidine Reduce Cutibacterium Acnes Contamination on Sutures in Arthroscopy Rotator Cuff Repair?
Primary Purpose
C. Acnes, Arthroscopic Rotator Cuff Repair
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
2% chlorhexidine gluconate skin cleanser
Sponsored by
About this trial
This is an interventional prevention trial for C. Acnes
Eligibility Criteria
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
Sites / Locations
- National Cheng Kung University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Extended shoulder group
Shoulder group
Control group
Arm Description
2% chlorhexidine gluconate skin cleanser over the not only the operative shoulder and axilla but also the chest, back, neck, and face
2% chlorhexidine gluconate skin cleanser over the operative shoulder and axilla
Skin prepare with soap as usual
Outcomes
Primary Outcome Measures
Culture positive
Culture positive for C. acnes from the suture used in the arthroscopy
Secondary Outcome Measures
Full Information
NCT ID
NCT04483063
First Posted
July 19, 2020
Last Updated
July 21, 2020
Sponsor
National Cheng-Kung University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04483063
Brief Title
Can Additional Preoperative Skin Cleaning on Face, Neck and Chest With Chlorhexidine Reduce Cutibacterium Acnes Contamination on Sutures in Arthroscopy Rotator Cuff Repair?
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?
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 23, 2020 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
June 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cheng-Kung University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
C. Acnes, Arthroscopic Rotator Cuff Repair
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Extended shoulder group
Arm Type
Experimental
Arm Description
2% chlorhexidine gluconate skin cleanser over the not only the operative shoulder and axilla but also the chest, back, neck, and face
Arm Title
Shoulder group
Arm Type
Experimental
Arm Description
2% chlorhexidine gluconate skin cleanser over the operative shoulder and axilla
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Skin prepare with soap as usual
Intervention Type
Drug
Intervention Name(s)
2% chlorhexidine gluconate skin cleanser
Intervention Description
2% chlorhexidine gluconate skin cleanser over shoulder region before shoulder surgery
Primary Outcome Measure Information:
Title
Culture positive
Description
Culture positive for C. acnes from the suture used in the arthroscopy
Time Frame
Within 2 weeks postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chih-Kai Hong, MD
Phone
886-6-2353535
Ext
5237
Email
yayahong@gmail.com
Facility Information:
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
70428
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
National Cheng Kung U Hospital
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Can Additional Preoperative Skin Cleaning on Face, Neck and Chest With Chlorhexidine Reduce Cutibacterium Acnes Contamination on Sutures in Arthroscopy Rotator Cuff Repair?
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