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

This study has been completed.
Sponsor:
Collaborator:
Sage Products, Inc.
Information provided by (Responsible Party):
Gordon Nuber, Northwestern University
ClinicalTrials.gov Identifier:
NCT01090479
First received: March 18, 2010
Last updated: April 30, 2013
Last verified: April 2013
  Purpose

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 Intervention
Post-operative Surgical Site Infections
Drug: 2% Chlorhexidine cloth

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Efficacy of Home Pre-Operative Use of 2% Chlorhexidine Cloths Prior to Shoulder Surgery

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Number of Patients With a Clinically Diagnosed Infection [ Time Frame: 2 months post-operatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Qualitative and Quantitative Bacterial Cultures of the Operative Shoulder Just Prior to Surgery [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: January 2010
Study Completion Date: October 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01090479

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

No publications provided by Northwestern University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gordon Nuber, Professor of Orthopaedics, Northwestern University
ClinicalTrials.gov Identifier: NCT01090479     History of Changes
Other Study ID Numbers: 2% Chlorhexidine Cloths
Study First Received: March 18, 2010
Results First Received: July 9, 2012
Last Updated: April 30, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
Surgical site infections
Chlorhexidine
Shoulder surgery

Additional relevant MeSH terms:
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Disinfectants
Dermatologic Agents

ClinicalTrials.gov processed this record on July 23, 2014