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Bacterial Colonization of Suction Drains Following Spine Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2016 by Western Galilee Hospital-Nahariya
Information provided by (Responsible Party):
Nimrod Rahamimov, Western Galilee Hospital-Nahariya Identifier:
First received: January 23, 2013
Last updated: May 7, 2016
Last verified: May 2016
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.

Surgical Site Infection, Closed Suction Drains

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Bacterial Colonization of Suction Drains Following Spine Surgery

Further study details as provided by Western Galilee Hospital-Nahariya:

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

Estimated Enrollment: 300
Study Start Date: January 2013
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01803490

Contact: Adi H Shani, R.N., B.A +972-4-9107310

Western Galilee Hospital Recruiting
Naharia, Israel, 22100
Contact: Nimrod T Rahamimov, M.D.    +972-50-7887564   
Principal Investigator: Nimrod T Rahamimov, M.D.         
Sponsors and Collaborators
Western Galilee Hospital-Nahariya
  More Information

Responsible Party: Nimrod Rahamimov, Head of Spine Surgery Unit, Western Galilee Hospital-Nahariya Identifier: NCT01803490     History of Changes
Other Study ID Numbers: 0076-12-NHR
Study First Received: January 23, 2013
Last Updated: May 7, 2016

Additional relevant MeSH terms:
Surgical Wound Infection
Wound Infection
Postoperative Complications
Pathologic Processes processed this record on May 25, 2017