Efficacy of Surgical Preparations in Lumbar Spine Surgery
Sponsor
Northwestern University (Other)
Overall Status
Completed
CT.gov ID
NCT01105195
Collaborator
3M (Industry)
100
1
2
10
10
Study Details
Study Description
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 |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Anticipated 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
:
Jan 1, 2010
Actual Primary Completion Date
:
Nov 1, 2010
Actual Study Completion Date
:
Nov 1, 2010
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- Positive culture results [7 days]
Our primary outcome measure is positive aerobic and/or anaerobic cultures reported at 7 days.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Northwestern Memorial Hospital | Chicago | Illinois | United States | 60611 |
Sponsors and Collaborators
- Northwestern University
- 3M
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- 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.
- 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.
Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT01105195
Other Study ID Numbers:
- STU00008875
First Posted:
Apr 16, 2010
Last Update Posted:
Nov 17, 2010
Last Verified:
Nov 1, 2010