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

NCT ID: NCT04483063

Last Updated: 2020-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-23

Study Completion Date

2022-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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C. Acnes Arthroscopic Rotator Cuff Repair

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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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

Group Type EXPERIMENTAL

2% chlorhexidine gluconate skin cleanser

Intervention Type DRUG

2% chlorhexidine gluconate skin cleanser over shoulder region before shoulder surgery

Shoulder group

2% chlorhexidine gluconate skin cleanser over the operative shoulder and axilla

Group Type EXPERIMENTAL

2% chlorhexidine gluconate skin cleanser

Intervention Type DRUG

2% chlorhexidine gluconate skin cleanser over shoulder region before shoulder surgery

Control group

Skin prepare with soap as usual

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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2% chlorhexidine gluconate skin cleanser

2% chlorhexidine gluconate skin cleanser over shoulder region before shoulder surgery

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cheng-Kung University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Kai-Lan Hsu

Attending physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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National Cheng Kung University Hospital

Tainan City, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Chih-Kai Hong, MD

Role: CONTACT

886-6-2353535 ext. 5237

Facility Contacts

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National Cheng Kung U Hospital

Role: primary

Other Identifiers

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B-BR-108-052

Identifier Type: -

Identifier Source: org_study_id

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