Bacterial Colonization of Suction Drains Following Spine Surgery

Surgical Site Infection, Closed Suction Drains Clinical Trial

Official title:

Bacterial Colonization of Suction Drains Following Spine Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01803490
• Other study ID #: 0076-12-NHR
• Status: Completed
• Start date: January 2013
• Est. completion date: April 27, 2019

Study information

• Verified date: May 2020
• Source: Western Galilee Hospital-Nahariya
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 224
• Est. completion date: April 27, 2019
• Est. primary completion date: April 27, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 120 Years

Eligibility

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.

Related Conditions & MeSH terms

• Surgical Site Infection, Closed Suction Drains
• Surgical Wound Infection

Locations

Country	Name	City	State
Israel	Western Galilee Hospital	Nahariya

Sponsors (1)

Lead Sponsor	Collaborator
Western Galilee Hospital-Nahariya

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Growth of bacteria in drain fluids		up to 10 days per patient, (from first post operative day until removal of drains).
Secondary	antibiotic level in drain fluid		up to 10 days per patient (from first post operative day until removal of drains).