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

Post-operative Surgical Site Infections Clinical Trial

Official title:

Efficacy of Home Pre-Operative Use of 2% Chlorhexidine Cloths Prior to Shoulder Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01090479
• Other study ID #: 2% Chlorhexidine Cloths
• Status: Completed
• Phase: N/A
• Start date: January 2010
• Est. completion date: October 2010

Study information

• Verified date: April 2023
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Other known NCT identifiers

• NCT00829023

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient undergoing shoulder surgery (open or arthroscopic)

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Post-operative Surgical Site Infections
• Surgical Wound Infection

Intervention

Drug:
• 2% Chlorhexidine cloth
The 2% Chlorhexidine cloth will be applied to the operative extremity the night prior and the the morning of their surgery.

Locations

Country	Name	City	State
United States	Northwestern Memorial Hospital	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	Sage Products, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients With a Clinically Diagnosed Infection		2 months post-operatively
Secondary	Qualitative and Quantitative Bacterial Cultures of the Operative Shoulder Just Prior to Surgery	Rate of positive cultures from entire shoulder region (combined from axilla and posterior shoulder)	7 days