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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Post-operative Surgical Site Infections

Intervention / Treatment
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* Drug: 2% Chlorhexidine cloth


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>This group will perform an ordinary shower the night prior and the morning of their scheduled surgery date. | |
| Experimental: 2% Chlorhexidine cloth<br>This group will use the 2% chlorhexidine wipes the night prior as well as the morning of their surgery date. | Drug: 2% Chlorhexidine cloth<br>* The 2% Chlorhexidine cloth will be applied to the operative extremity the night prior and the the morning of their surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With a Clinically Diagnosed Infection |  | 2 months post-operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Surgical site infections, Chlorhexidine, Shoulder surgery