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

Northwestern University

Status: Completed

Conditions: Post-operative Surgical Site Infections

Treatments: Drug: 2% Chlorhexidine cloth

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01090479

2% Chlorhexidine Cloths

Details and patient eligibility

About

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.

Full 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).

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Control

No Intervention group

Description:

This group will perform an ordinary shower the night prior and the morning of their scheduled surgery date.

2% Chlorhexidine cloth

Experimental group

Description:

This group will use the 2% chlorhexidine wipes the night prior as well as the morning of their surgery date.

Treatment:

Drug: 2% Chlorhexidine cloth