Bacterial Colonization of Suction Drains Following Spine Surgery

NCT ID: NCT01803490

Last Updated: 2020-05-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 224 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2019-04-27

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.

Conditions

Surgical Site Infection, Closed Suction Drains

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Exclusion Criteria

• Known active infection in the spine or elsewhere.

• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Western Galilee Hospital-Nahariya

OTHER_GOV

Sponsor Role: lead

Responsible Party

Nimrod Rahamimov

Head of Spine Surgery Unit

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

nimrod t Rahamimov, md

Role: PRINCIPAL_INVESTIGATOR

Head, Dept. of Orthopedics and spine surgery

Locations

Western Galilee Hospital

Nahariya, , Israel

Countries

Israel

Other Identifiers

0076-12-NHR

Identifier Type: -

Identifier Source: org_study_id