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NCT00829023 Clinical Trial

Efficacy of Surgical Preparation Solutions in Shoulder Surgery

Shoulder Surgery Clinical Trial

Official title:
Efficacy of Surgical Preparation Solutions in Shoulder Surgery

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00829023
Other study ID # IRB 1232-008
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 2007
Est. completion date June 2008

Study information
Verified date February 2023
Source Northwestern University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 150
Est. completion date June 2008
Est. primary completion date June 2008
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria: - shoulder surgery or any type Exclusion Criteria: - open wound, current infection, chronic immunosuppression

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Northwestern Memorial Hospital Chicago Illinois

Sponsors (2)
Lead Sponsor Collaborator
Northwestern University CareFusion

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary positive culture results rate of positive cultures 7 days
Secondary infection rate of infection 6 months
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