Bacterial Colonization of Suction Drains Following Spine Surgery

May 25, 2020 updated by: Nimrod Rahamimov, Western Galilee Hospital-Nahariya
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 Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

224

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Nahariya, Israel, 22100
        • Western Galilee Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 120 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing elective or emergent spine surgery in the normal course of activity at the Western Galilee Hospital spine surgery unit.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Growth of bacteria in drain fluids
Time Frame: up to 10 days per patient, (from first post operative day until removal of drains).
up to 10 days per patient, (from first post operative day until removal of drains).

Secondary Outcome Measures

Outcome Measure
Time Frame
antibiotic level in drain fluid
Time Frame: up to 10 days per patient (from first post operative day until removal of drains).
up to 10 days per patient (from first post operative day until removal of drains).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Western Galilee Hospital-Nahariya

Investigators

  • Principal Investigator: nimrod t Rahamimov, md, Head, Dept. of Orthopedics and spine surgery

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

April 27, 2019

Study Completion (Actual)

April 27, 2019

Study Registration Dates

First Submitted

January 23, 2013

First Submitted That Met QC Criteria

March 1, 2013

First Posted (Estimate)

March 4, 2013

Study Record Updates

Last Update Posted (Actual)

May 27, 2020

Last Update Submitted That Met QC Criteria

May 25, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0076-12-NHR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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