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CompletedNCT03408782Updated Jan 24, 2018

Drains and Surgical Site Infections

An observational study in Surgical Site Infection, sponsored by University Hospital, Basel, Switzerland. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-01-24.

Sponsored by University Hospital, Basel, Switzerland · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
4,584
Ages
18 Years and older
Sex
All
01

Study summary

This prospective observational study examines the associations of presence, duration, type, number and location of surgical drains with the risk of surgical site infections in a contemporary and multicentric cohort of general, orthopedic trauma and vascular surgery procedures.

Read the detailed description

Surgical site infections (SSI) represent the most common type of nosocomial infection amongst surgical patients. They cause morbidity and mortality.

Surgical Drains are commonly inserted at the end of many surgical procedures. In contrast to potential benefits, drains are also thought to potentially serve as a conduit of bacteria into the wound and hence may increase the risk of SSI. Patterns of use of drains vary widely across surgical disciplines and individual practices. There are no uniform guidelines and standards are often rather based on tradition than on evidence. The aim of this large prospective study was to examine the association of presence, duration, type, number and location of drains with the risk of SSI in a contemporary and multicentric cohort of general, orthopedic trauma and vascular surgery procedures.

02

Conditions studied

  • Surgical Site Infection

Keywords

  • Surgical Site Infection
  • Surgical drains
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

This observational study is nested in a multicenter randomized controlled trial that was designed to evaluate the optimal timing of surgical antimicrobial prophylaxis in a general, orthopedic trauma and vascular surgery population. The term "general surgery" refers to gastrointestinal, oncologic breast, endocrine and hernia surgery. The study centers are two tertiarry referral hospitals in Switzerland. All patients included in the randomized controlled trial are included in this observational study as well.

Inclusion criteria

  • Inpatients
  • Age 18 years or older
  • General, orthopedic trauma and vascular procedures
  • Surgical antimicrobial prophylaxis

Exclusion criteria

Exclusion Criteria:

  • outpatient surgery
  • Presence of a contraindication for cefuroxime and/or metronidazole
  • preexisting antibiotic therapy within 14 days prior to surgery
  • cognitive impairment
  • combined operations including other than the above specified surgical divisions
  • Emergency procedures with planned incision within 2 hours after indicating the procedure.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
4,584 participants (actual)
Patient registry
No

Groups and cohorts

  • No drainage

    Those patients that underwent surgery and no drain was inserted at the end of the procedure

  • Drainage

    Those patients that underwent surgery and one or several drains were inserted at the end of the procedure.

    Procedure: Insertion of drainage

Interventions

  • ProcedureInsertion of drainage
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What researchers measure

Primary outcomes

  1. Surgical site infection

    The occurrence of surgical site infection according to CDC criteria

    Time frame: 30 days

06

Study locations

No study locations are listed for this record.

07

References and documents

Publications

  • Weber WP, Mujagic E, Zwahlen M, Bundi M, Hoffmann H, Soysal SD, Kraljevic M, Delko T, von Strauss M, Iselin L, Da Silva RXS, Zeindler J, Rosenthal R, Misteli H, Kindler C, Muller P, Saccilotto R, Lugli AK, Kaufmann M, Gurke L, von Holzen U, Oertli D, Bucheli-Laffer E, Landin J, Widmer AF, Fux CA, Marti WR. Timing of surgical antimicrobial prophylaxis: a phase 3 randomised controlled trial. Lancet Infect Dis. 2017 Jun;17(6):605-614. doi: 10.1016/S1473-3099(17)30176-7. Epub 2017 Apr 3. Erratum In: Lancet Infect Dis. 2017 Dec;17(12):1232. doi: 10.1016/S1473-3099(17)30611-4. PubMed 28385346 ↗
  • Mujagic E, Zwimpfer T, Marti WR, Zwahlen M, Hoffmann H, Kindler C, Fux C, Misteli H, Iselin L, Lugli AK, Nebiker CA, von Holzen U, Vinzens F, von Strauss M, Reck S, Kraljevic M, Widmer AF, Oertli D, Rosenthal R, Weber WP. Evaluating the optimal timing of surgical antimicrobial prophylaxis: study protocol for a randomized controlled trial. Trials. 2014 May 24;15:188. doi: 10.1186/1745-6215-15-188. PubMed 24885132 ↗

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT03408782
Lead sponsor
University Hospital, Basel, Switzerland
Responsible party
Edin Mujagic (Edin Mujagic, MD, University Hospital, Basel, Switzerland) — Principal investigator
First posted
Jan 24, 2018
Start date
Feb 22, 2013
Primary completion
Aug 31, 2015
Completion
Aug 31, 2015
Last update
Jan 24, 2018

Study contacts

Edin Mujagic, MD
principal investigator · University Hospital, Basel, Switzerland

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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