Efficacy of Surgical Preparations in Lumbar Spine Surgery

Infection Clinical Trial

Official title:

Efficacy of Surgical Preparations in Lumbar Spine Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01105195
• Other study ID #: STU00008875
• Status: Completed
• Phase: N/A
• First received: April 12, 2010
• Last updated: November 16, 2010
• Start date: January 2010
• Est. completion date: November 2010

Study information

• Verified date: November 2010
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infection

Intervention

Other:
• DuraPrep
DuraPrep is used for skin preparation prior to surgery.
• ChloraPrep
ChloraPrep is used for skin preparation prior to surgery.

Locations

Country	Name	City	State
United States	Northwestern Memorial Hospital	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	3M

Country where clinical trial is conducted

United States, 

References & Publications (2)

Ostrander RV, Botte MJ, Brage ME. Efficacy of surgical preparation solutions in foot and ankle surgery. J Bone Joint Surg Am. 2005 May;87(5):980-5. — View Citation

Saltzman MD, Nuber GW, Gryzlo SM, Marecek GS, Koh JL. Efficacy of surgical preparation solutions in shoulder surgery. J Bone Joint Surg Am. 2009 Aug;91(8):1949-53. doi: 10.2106/JBJS.H.00768. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positive culture results	Our primary outcome measure is positive aerobic and/or anaerobic cultures reported at 7 days.	7 days