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Completed

NCT Number: NCT01090479

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

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.

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Key information

Conditions

Post-operative Surgical Site Infections Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Surgical Wound Infection Wound Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

2% Chlorhexidine cloth

Drug

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

Primary outcomes

  1. Number of Patients With a Clinically Diagnosed Infection

    Time frame: 2 months post-operatively

Secondary outcomes

  1. Qualitative and Quantitative Bacterial Cultures of the Operative Shoulder Just Prior to Surgery

    Time frame: 7 days

    Rate of positive cultures from entire shoulder region (combined from axilla and posterior shoulder)

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • Sage Products, Inc.

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Mar 22, 2010
Registry last updated
May 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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