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Efficacy of Surgical Preparation Solutions in Shoulder Surgery

This study has been completed.
Sponsor:
Collaborator:
CareFusion
Information provided by:
Northwestern University
ClinicalTrials.gov Identifier:
NCT00829023
First received: January 21, 2009
Last updated: January 23, 2009
Last verified: January 2009
History of Changes
  Purpose

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.


Condition Intervention
Shoulder Surgery
 Other: chlorhexidine gluconate and isopropyl alcohol, iodophor and isopropyl alcohol, povidone-iodine scrub and paint

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Efficacy of Surgical Preparation Solutions in Shoulder Surgery

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • positive culture results [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • infection [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 150
Study Start Date: June 2007
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: betadine, DuraPrep, ChloraPrep
surgical skin preparation solution
 Other: chlorhexidine gluconate and isopropyl alcohol, iodophor and isopropyl alcohol, povidone-iodine scrub and paint
surgical skin preparation solutions

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • shoulder surgery or any type

Exclusion Criteria:

  • open wound, current infection, chronic immunosuppression
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00829023

Locations
United States, Illinois
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
CareFusion
Investigators
Principal Investigator: Jason L Koh, MD Northwestern Memorial Faculty Foundation
  More Information

No publications provided by Northwestern University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Jason L. Koh, MD, Northwestern Memorial Faculty Foundation
ClinicalTrials.gov Identifier: NCT00829023     History of Changes
Other Study ID Numbers: IRB 1232-008
Study First Received: January 21, 2009
Last Updated: January 23, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
Positive aerobic or anaerobic cultures

Additional relevant MeSH terms:
Ethanol
Chlorhexidine
Chlorhexidine gluconate
Povidone-Iodine
Povidone
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
 Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents
Plasma Substitutes
Blood Substitutes
Hematologic Agents
Disinfectants
Dermatologic Agents

ClinicalTrials.gov processed this record on May 22, 2013