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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01090479
Recruitment Status : Completed
First Posted : March 22, 2010
Results First Posted : August 14, 2012
Last Update Posted : May 6, 2013
Sage Products, Inc.
Information provided by (Responsible Party):
Gordon Nuber, 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.

Condition or disease Intervention/treatment Phase
Post-operative Surgical Site Infections Drug: 2% Chlorhexidine cloth Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Efficacy of Home Pre-Operative Use of 2% Chlorhexidine Cloths Prior to Shoulder Surgery
Study Start Date : January 2010
Actual Primary Completion Date : August 2010
Actual Study Completion Date : October 2010

Arm Intervention/treatment
No Intervention: Control
This group will perform an ordinary shower the night prior and the morning of their scheduled surgery date.
Experimental: 2% Chlorhexidine cloth
This group will use the 2% chlorhexidine wipes the night prior as well as the morning of their surgery date.
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.

Primary Outcome Measures :
  1. Number of Patients With a Clinically Diagnosed Infection [ Time Frame: 2 months post-operatively ]

Secondary Outcome Measures :
  1. Qualitative and Quantitative Bacterial Cultures of the Operative Shoulder Just Prior to Surgery [ Time Frame: 7 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01090479

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United States, Illinois
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Sage Products, Inc.
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Principal Investigator: Gordon Nuber, M.D. Professor of Orthopaedic Surgery

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Gordon Nuber, Professor of Orthopaedics, Northwestern University Identifier: NCT01090479     History of Changes
Other Study ID Numbers: 2% Chlorhexidine Cloths
First Posted: March 22, 2010    Key Record Dates
Results First Posted: August 14, 2012
Last Update Posted: May 6, 2013
Last Verified: April 2013

Keywords provided by Gordon Nuber, Northwestern University:
Surgical site infections
Shoulder surgery

Additional relevant MeSH terms:
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Chlorhexidine gluconate
Surgical Wound Infection
Wound Infection
Postoperative Complications
Pathologic Processes
Anti-Infective Agents, Local
Anti-Infective Agents
Dermatologic Agents