Surgical Site Infection, Closed Suction DrainsNCT01803490
Bacterial Colonization of Suction Drains Following Spine Surgery
An observational study of Surgical Site Infection, Closed Suction Drains, run by Western Galilee Hospital-Nahariya at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages Up to 120 years
- Conditions the study is for
- Surgical Site Infection, Closed Suction Drains
- How many people
- 224 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2013to 27 Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 120 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients undergoing elective or emergent spine surgery in the normal course of activity at the Western Galilee Hospital spine surgery unit.
Who may be able to join
- All patients undergoing spine surgery that requires suction draining,and do not meet the exclusion criteria for this study.
Who cannot join
- Known active infection in the spine or elsewhere.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Medical subject headings
- Surgical Wound Infection
What is being measured
The primary outcome is the main question the study is designed to answer.
Growth of bacteria in drain fluids
Measured: up to 10 days per patient, (from first post operative day until removal of drains).
Secondary outcomes (1)
antibiotic level in drain fluid
Measured: up to 10 days per patient (from first post operative day until removal of drains).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2013 (estimated)
- Study startJan 2013
- Primary completion27 Apr 2019
- Study completion27 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Site Infection, Closed Suction DrainsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western Galilee Hospital-Nahariya
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Nimrod Rahamimov, Western Galilee Hospital-Nahariya
- Investigators
- nimrod t Rahamimov, md, Principal investigator, Head, Dept. of Orthopedics and spine surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01803490
- Sponsor's protocol ID
- 0076-12-NHR
- Status last verified
- May 2020
- First submitted
- 23 Jan 2013
- Last updated
- 27 May 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bacterial Colonization of Suction Drains Following Spine Surgery
- ClinicalTrials.gov ID
- NCT01803490
- Acronym / sponsor ID
- 0076-12-NHR
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- Western Galilee Hospital-NahariyaOther government
- Study start
- Jan 2013
- Primary completion
- 27 Apr 2019 (actual)
- Study completion
- 27 Apr 2019 (actual)
- First posted
- 4 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing elective or emergent spine surgery in the normal course of activity at the Western Galilee Hospital spine surgery unit.
Key inclusion criteria (1 listed)
- All patients undergoing spine surgery that requires suction draining,and do not meet the exclusion criteria for this study.
Key exclusion criteria (1 listed)
- Known active infection in the spine or elsewhere.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Growth of bacteria in drain fluids
Time frame: up to 10 days per patient, (from first post operative day until removal of drains).
1 secondary outcome
antibiotic level in drain fluid
Time frame: up to 10 days per patient (from first post operative day until removal of drains).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2020.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
nimrod t Rahamimov, md principal investigator
Head, Dept. of Orthopedics and spine surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgical Site Infection, Closed Suction Drains, run by Western Galilee Hospital-Nahariya at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Growth of bacteria in drain fluids (time frame: up to 10 days per patient, (from first post operative day until removal of drains).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2020.