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

April 25, 2023 updated by: Gordon Nuber, Northwestern University

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Patients With a Clinically Diagnosed Infection
Time Frame: 2 months post-operatively
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
Time Frame: 7 days
Rate of positive cultures from entire shoulder region (combined from axilla and posterior shoulder)
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Collaborators

Sage Products, Inc.

Investigators

  • Principal Investigator: Gordon Nuber, M.D., Professor of Orthopaedic Surgery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

March 18, 2010

First Submitted That Met QC Criteria

March 19, 2010

First Posted (Estimate)

March 22, 2010

Study Record Updates

Last Update Posted (Actual)

May 23, 2023

Last Update Submitted That Met QC Criteria

April 25, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2% Chlorhexidine Cloths

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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