Efficacy of Surgical Preparation Solutions in Shoulder Surgery - Full Text View

Sponsors and Collaborators:	Northwestern University Enturia
Information provided by:	Northwestern University
ClinicalTrials.gov Identifier:	NCT00829023

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:	Prevention, Randomized, Double Blind (Subject, Outcomes Assessor), Uncontrolled, Parallel Assignment, Efficacy Study
Official Title:	Efficacy of Surgical Preparation Solutions in Shoulder Surgery

Resource links provided by NLM:

MedlinePlus related topics: Surgery

Drug Information available for: Chlorhexidine Ethanol 2-Propanol Chlorhexidine digluconate Povidone-iodine Hibiclens Cadexomer iodine Gluconic acid D-Gluconic acid, monosodium salt Manganese gluconate Iodine Povidone

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
betadine, DuraPrep, ChloraPrep: Experimental 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

Enturia

Investigators

Principal Investigator:

Jason L Koh, MD

Northwestern Memorial Faculty Foundation

More Information

No publications provided

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

Keywords provided by Northwestern University:

Positive aerobic or anaerobic cultures

Study placed in the following topic categories:

Anti-Infective Agents
Anti-Infective Agents, Local
Disinfectants
Chlorhexidine
Chlorhexidine gluconate

Povidone
Iodine
Povidone-Iodine
Ethanol

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Infective Agents, Local
Disinfectants
Chlorhexidine
Chlorhexidine gluconate

Therapeutic Uses
Povidone-Iodine
Dermatologic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 10, 2009