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

April 12, 2010
November 16, 2010
January 2010
November 2010   (final data collection date for primary outcome measure)
Positive culture results [ Time Frame: 7 days ]
Our primary outcome measure is positive aerobic and/or anaerobic cultures reported at 7 days.
Same as current
Complete list of historical versions of study NCT01105195 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Efficacy of Surgical Preparations in Lumbar Spine Surgery
Efficacy of Surgical Preparations in Lumbar Spine Surgery

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).

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Infection
  • Other: DuraPrep
    DuraPrep is used for skin preparation prior to surgery.
  • Other: ChloraPrep
    ChloraPrep is used for skin preparation prior to surgery.
  • Active Comparator: DuraPrep
    Intervention: Other: DuraPrep
  • Active Comparator: ChloraPrep
    Intervention: Other: ChloraPrep

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
November 2010
November 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01105195
STU00008875
No
Michael Haak, MD, Northwestern University Feinberg School of Medicine
Northwestern University
3M
Not Provided
Northwestern University
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP