NCT01105195

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 12, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 16, 2010

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

November 17, 2010

Status Verified

November 1, 2010

Enrollment Period

10 months

First QC Date

April 12, 2010

Last Update Submit

November 16, 2010

Conditions

Infection

Keywords

DuraPrepChloraPrepLumbar Spine

Outcome Measures

Primary Outcomes (1)

  • Positive culture results

    Our primary outcome measure is positive aerobic and/or anaerobic cultures reported at 7 days.

    7 days

Study Arms (2)

DuraPrep

ACTIVE COMPARATOR
Other: DuraPrep

ChloraPrep

ACTIVE COMPARATOR
Other: ChloraPrep

Interventions

DuraPrepOTHER

DuraPrep is used for skin preparation prior to surgery.

DuraPrep
ChloraPrepOTHER

ChloraPrep is used for skin preparation prior to surgery.

ChloraPrep

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients undergoing lumbar spine surgery (discectomy, laminectomy, fusion, etc).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Related Publications (2)

  • 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.

    PMID: 19651954BACKGROUND

  • 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. doi: 10.2106/JBJS.D.01977.

    PMID: 15866959BACKGROUND

Related Links

MeSH Terms

Conditions

Infections

Interventions

DuraPrep

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 12, 2010

First Posted

April 16, 2010

Study Start

January 1, 2010

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

November 17, 2010

Record last verified: 2010-11

Locations

US(1)