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Efficacy of Surgical Preparations in Lumbar Spine Surgery

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ClinicalTrials.gov Identifier: NCT01105195
Recruitment Status : Completed
First Posted : April 16, 2010
Last Update Posted : November 17, 2010
Sponsor:
Collaborator:
3M
Information provided by:
Northwestern University

Brief Summary:
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 or disease Intervention/treatment Phase
Infection Other: DuraPrep Other: ChloraPrep Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Efficacy of Surgical Preparations in Lumbar Spine Surgery
Study Start Date : January 2010
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Positive culture results [ Time Frame: 7 days ]
    Our primary outcome measure is positive aerobic and/or anaerobic cultures reported at 7 days.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

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

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 Posted: April 16, 2010    Key Record Dates
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
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents