We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy of Surgical Preparations in Lumbar Spine Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01105195
First Posted: April 16, 2010
Last Update Posted: November 17, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
3M
Information provided by:
Northwestern University
  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
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Efficacy of Surgical Preparations in Lumbar Spine Surgery

Resource links provided by NLM:


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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01105195


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

Additional Information:
Publications:
Responsible Party: Michael Haak, MD, Northwestern University Feinberg School of Medicine
ClinicalTrials.gov Identifier: NCT01105195     History of Changes
Other Study ID Numbers: STU00008875
First Submitted: April 12, 2010
First Posted: April 16, 2010
Last Update Posted: November 17, 2010
Last Verified: November 2010

Keywords provided by Northwestern University:
DuraPrep
ChloraPrep
Lumbar Spine

Additional relevant MeSH terms:
Chlorhexidine
Chlorhexidine gluconate
Iodine
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs