Efficacy of Surgical Preparation Solutions in Shoulder Surgery

February 23, 2023 updated by: Matthew Saltzman, Northwestern University
The purpose of the present study was to examine the native bacteria around the shoulder and determine the efficacy of three different surgical skin-preparation solutions on the eradication of bacteria from the shoulder.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A prospective study was undertaken to evaluate 150 consecutive patients undergoing shoulder surgery at one institution. Each shoulder was prepared with one of three randomly selected solutions: ChloraPrep (2% chlorhexidine gluconate and 70% isopropyl alcohol), DuraPrep (0.7% iodophor and 74% isopropyl alcohol), or povidone-iodine scrub and paint (0.75% iodine scrub, 1.0% iodine paint). Aerobic and anaerobic cultures were taken prior to skin preparation for the first twenty patients to determine the native bacteria around the shoulder and following skin preparation for all patients.

Study Type

Interventional

Enrollment (Actual)

150

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 to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • shoulder surgery or any type

Exclusion Criteria:

  • open wound, current infection, chronic immunosuppression

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
Active Comparator: ChloraPrep
ChloraPrep (2% chlorhexidine gluconate and 70% isopropyl alcohol)
Drug: ChloraPrep Topical Product
surgical skin preparation solution 2% chlorhexidine gluconate and 70% isopropyl alcohol
Active Comparator: DuraPrep
DuraPrep (0.7% iodophor and 74% isopropyl alcohol)
Drug: Duraprep Surgical Topical Solution
surgical skin preparation solution 0.7% iodophor and 74% isopropyl alcohol
Active Comparator: povidone-iodine scrub and paint
povidone-iodine scrub and paint (0.75% iodine scrub and 1.0% iodine paint)
Drug: povidone-iodine scrub and paint
surgical skin preparation solution 0.75% iodine scrub and 1.0% iodine paint

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
positive culture results
Time Frame: 7 days
rate of positive cultures
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
infection
Time Frame: 6 months
rate of infection
6 months

Collaborators and Investigators

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

Sponsor

Northwestern University

Collaborators

CareFusion

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

June 1, 2007

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

January 21, 2009

First Submitted That Met QC Criteria

January 23, 2009

First Posted (Estimate)

January 26, 2009

Study Record Updates

Last Update Posted (Estimate)

February 27, 2023

Last Update Submitted That Met QC Criteria

February 23, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB 1232-008

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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