Bacterial Colonization of Suction Drains Following Spine Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Western Galilee Hospital-Nahariya
Sponsor:
Information provided by (Responsible Party):
Nimrod Rahamimov, Western Galilee Hospital-Nahariya
ClinicalTrials.gov Identifier:
NCT01803490
First received: January 23, 2013
Last updated: March 1, 2013
Last verified: February 2013
  Purpose

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
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). ] [ Designated as safety issue: No ]

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). ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: January 2013
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
  Eligibility

Genders Eligible for Study:   Both
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.

Criteria

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 ClinicalTrials.gov identifier: NCT01803490

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

Locations
Israel
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
  More Information

No publications provided

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
Study First Received: January 23, 2013
Last Updated: March 1, 2013
Health Authority: Israel: Ministry of Health

ClinicalTrials.gov processed this record on July 20, 2014