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Clinical Trials/NCT01803490
NCT01803490CompletedNot Applicable

Bacterial Colonization of Suction Drains Following Spine Surgery

Western Galilee Hospital-Nahariya1 site in 1 country224 target enrollmentStarted: January 2013Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
224
Locations
1
Primary Endpoint
Growth of bacteria in drain fluids

Study Overview

Brief Summary

Closed suction drains are commonly used following surgery, if the wound is expected to discharge significant amounts of fluid. To this date, no evidence base exists as to the exact post operative time period or discharge volume necessitating presence of a drain. In orthopedic common practice, drains are removed on the second post operative day, fearing the drain will serve as a point of entry for nosocomial infection. In this study, drains will be left in place as long as daily discharge volume exceeds 50cc, regardless of the amount of days following surgery. Daily cultures and antibiotic levels will be taken from the drains receptacle, to determine if and when the drains is colonized by aerobic bacteria.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
— to 120 Years (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • All patients undergoing spine surgery that requires suction draining,and do not meet the exclusion criteria for this study.

Exclusion Criteria

  • Known active infection in the spine or elsewhere.

Outcomes

Primary Outcomes

Growth of bacteria in drain fluids

Time Frame: up to 10 days per patient, (from first post operative day until removal of drains).

Secondary Outcomes

  • antibiotic level in drain fluid(up to 10 days per patient (from first post operative day until removal of drains).)

Investigators

Sponsor Class
Other Gov
Responsible Party
Principal Investigator
Principal Investigator

Nimrod Rahamimov

Head of Spine Surgery Unit

Western Galilee Hospital-Nahariya

Study Sites (1)

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