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Bacterial Colonization of Suction Drains Following Spine Surgery

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ClinicalTrials.gov Identifier: NCT01803490
Recruitment Status : Recruiting
First Posted : March 4, 2013
Last Update Posted : May 10, 2016
Information provided by (Responsible Party):
Nimrod Rahamimov, Western Galilee Hospital-Nahariya

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.

Condition or disease
Surgical Site Infection, Closed Suction Drains

Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Bacterial Colonization of Suction Drains Following Spine Surgery
Study Start Date : January 2013
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : January 2017

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

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

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Ages Eligible for Study:   up to 120 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01803490

Contact: Adi H Shani, R.N., B.A +972-4-9107310 adi.shani@naharia.health.gov.il

Western Galilee Hospital Recruiting
Naharia, Israel, 22100
Contact: Nimrod T Rahamimov, M.D.    +972-50-7887564    nimrod.rahamimov@naharia.health.gov.il   
Principal Investigator: Nimrod T Rahamimov, M.D.         
Sponsors and Collaborators
Western Galilee Hospital-Nahariya

Responsible Party: Nimrod Rahamimov, Head of Spine Surgery Unit, Western Galilee Hospital-Nahariya
ClinicalTrials.gov Identifier: NCT01803490     History of Changes
Other Study ID Numbers: 0076-12-NHR
First Posted: March 4, 2013    Key Record Dates
Last Update Posted: May 10, 2016
Last Verified: May 2016

Additional relevant MeSH terms:
Surgical Wound Infection
Wound Infection
Postoperative Complications
Pathologic Processes