NCT04483063

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 23, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 19, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 23, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

July 23, 2020

Status Verified

July 1, 2020

Enrollment Period

1.8 years

First QC Date

July 19, 2020

Last Update Submit

July 21, 2020

Conditions

C. AcnesArthroscopic Rotator Cuff Repair

Outcome Measures

Primary Outcomes (1)

  • Culture positive

    Culture positive for C. acnes from the suture used in the arthroscopy

    Within 2 weeks postoperatively

Study Arms (3)

Extended shoulder group

EXPERIMENTAL

2% chlorhexidine gluconate skin cleanser over the not only the operative shoulder and axilla but also the chest, back, neck, and face

Drug: 2% chlorhexidine gluconate skin cleanser

Shoulder group

EXPERIMENTAL

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

Drug: 2% chlorhexidine gluconate skin cleanser

Control group

NO INTERVENTION

Skin prepare with soap as usual

Interventions

2% chlorhexidine gluconate skin cleanserDRUG

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

Extended shoulder groupShoulder group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • primary arthroscopic rotator cuff repair

You may not qualify if:

  • younger than 18 years
  • having previous shoulder surgeries or shoulder infection episodes
  • having a history of allergy to chlorhexidine
  • who refused to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cheng Kung University Hospital

Tainan, 70428, Taiwan

RECRUITING

Central Study Contacts

Chih-Kai Hong, MD

CONTACT

886-6-2353535yayahong@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending physician

Study Record Dates

First Submitted

July 19, 2020

First Posted

July 23, 2020

Study Start

March 23, 2020

Primary Completion

December 31, 2021

Study Completion

June 30, 2022

Last Updated

July 23, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)