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Efficacy of Surgical Preparations in Lumbar Spine Surgery

This study has been completed.
Sponsor:
Collaborator:
3M
Information provided by:
Northwestern University
ClinicalTrials.gov Identifier:
NCT01105195
First received: April 12, 2010
Last updated: November 16, 2010
Last verified: November 2010
History of Changes
  Purpose

The purpose of this study is to 1) identify the common bacterial flora found on the skin overlying the lumbar spine, and 2) evaluate the efficacy of readily available skin-preparation solutions in the elimination of bacterial pathogens from the surgical site following skin preparation (DuraPrep versus ChloraPrep).


Condition Intervention
Infection
 Other: DuraPrep
Other: ChloraPrep

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Efficacy of Surgical Preparations in Lumbar Spine 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 ]
    Our primary outcome measure is positive aerobic and/or anaerobic cultures reported at 7 days.


Estimated Enrollment: 100
Study Start Date: January 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: DuraPrep Other: DuraPrep
DuraPrep is used for skin preparation prior to surgery.
Active Comparator: ChloraPrep Other: ChloraPrep
ChloraPrep is used for skin preparation prior to surgery.

  Eligibility

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

Inclusion Criteria:

  • All patients undergoing lumbar spine surgery (discectomy, laminectomy, fusion, etc).

Exclusion Criteria:

  • Open wound at the incision site,
  • Abrasion in the vicinity of the incision site,
  • An active infection at or near the surgical site, or
  • An active infection elsewhere in the body.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01105195

Locations
United States, Illinois
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
3M
  More Information

Additional Information:
Information on ChloraPrep  This link exits the ClinicalTrials.gov site
Information on DuraPrep  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Michael Haak, MD, Northwestern University Feinberg School of Medicine
ClinicalTrials.gov Identifier: NCT01105195     History of Changes
Other Study ID Numbers: STU00008875
Study First Received: April 12, 2010
Last Updated: November 16, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
DuraPrep
ChloraPrep
Lumbar Spine

Additional relevant MeSH terms:
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
 Therapeutic Uses
Pharmacologic Actions
Disinfectants
Dermatologic Agents

ClinicalTrials.gov processed this record on June 13, 2013