- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04483063
Can Additional Preoperative Skin Cleaning on Face, Neck and Chest With Chlorhexidine Reduce Cutibacterium Acnes Contamination on Sutures in Arthroscopy Rotator Cuff Repair?
July 21, 2020 updated by: Kai-Lan Hsu, National Cheng-Kung University Hospital
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
90
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, MD
- Phone Number: 5237 886-6-2353535
- Email: yayahong@gmail.com
Study Locations
-
-
-
Tainan, Taiwan, 70428
- Recruiting
- National Cheng Kung University Hospital
-
Contact:
- National Cheng Kung U Hospital
-
-
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
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
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: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Extended shoulder group
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 shoulder region before shoulder surgery
|
Experimental: Shoulder group
2% chlorhexidine gluconate skin cleanser over the operative shoulder and axilla
|
2% chlorhexidine gluconate skin cleanser over shoulder region before shoulder surgery
|
No Intervention: Control group
Skin prepare with soap as usual
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Culture positive
Time Frame: Within 2 weeks postoperatively
|
Culture positive for C. acnes from the suture used in the arthroscopy
|
Within 2 weeks postoperatively
|
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 (Actual)
March 23, 2020
Primary Completion (Anticipated)
December 31, 2021
Study Completion (Anticipated)
June 30, 2022
Study Registration Dates
First Submitted
July 19, 2020
First Submitted That Met QC Criteria
July 21, 2020
First Posted (Actual)
July 23, 2020
Study Record Updates
Last Update Posted (Actual)
July 23, 2020
Last Update Submitted That Met QC Criteria
July 21, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- B-BR-108-052
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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