Pre-operative Preparation Using 2% Chlorhexidine Cloth For Shoulder Surgery

Not Applicable

Completed

• Conditions: Post-operative Surgical Site Infections
• Interventions: Drug: 2% Chlorhexidine cloth

• Registration Number: NCT01090479
• Lead Sponsor: Northwestern University

Brief Summary

We intend to determine how effective the use of a 2% Chlorhexidine Cloth is in terms of eliminating the bacterial load on patients undergoing shoulder surgery. We will be comparing the Chlorhexidine Cloths with a control group which will be performing an ordinary shower prior to surgery. At this time, it is standard of care to only take an ordinary shower the evening prior, and the morning of surgery.

Detailed Description

The use of home preoperative chlorhexidine wash has been used in various surgical fields for the prevention of perioperative infections. However, it's use in shoulder surgery has not been published up to this point. The shoulder has a unique microbial flora due to the prevalence of Propionibacterium acnes, a bacteria implicated in surgical site infections after shoulder surgery. This study is designed to examine the efficacy of using a preoperative Sage 2% chlorhexidine cloth in reducing bacterial load in the pre-operative area as well as in reducing post-operative surgical site infections after shoulder surgery. This study will compare the rate of post-operative infections and also the rate of positive skin cultures. The skin cultures will be obtained in the preoperative area from subjects who used the Sage 2% Chlorhexidine cloth protocol pre-operatively (n=50) versus those who used only soap and water (n=50).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-03-18
• Study First Submitted QC: 2010-03-19
• Study First Posted: 2010-03-22
• Primary Completion: 2010-08
• Study Completion: 2010-10
• Results First Submitted: 2012-07-09
• Results First Submitted QC: 2012-07-09
• Results First Posted: 2012-08-14
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-25
• Last Update Posted: 2023-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patient undergoing shoulder surgery (open or arthroscopic)

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Exclusion Criteria

• Patient unwilling to comply with instructions
• Active infection in the operative extremity
• Documented allergic reaction to chlorhexidine

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2% Chlorhexidine cloth	2% Chlorhexidine cloth	This group will use the 2% chlorhexidine wipes the night prior as well as the morning of their surgery date.

Primary Outcome Measures

Name	Time	Method
Number of Patients With a Clinically Diagnosed Infection	2 months post-operatively

Secondary Outcome Measures

Name	Time	Method
Qualitative and Quantitative Bacterial Cultures of the Operative Shoulder Just Prior to Surgery	7 days	Rate of positive cultures from entire shoulder region (combined from axilla and posterior shoulder)

Trial Locations

Locations (1)

Northwestern Memorial Hospital; 🇺🇸 Chicago, Illinois, United States