Drains and Surgical Site Infections

Overview

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.

Full Title of Study: “The Association of Surgical Drains With the Risk of Surgical Site Infection – a Prospective Observational Study”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: August 31, 2015

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.

Interventions

  • Procedure: Insertion of drainage

Arms, 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.

Clinical Trial Outcome Measures

Primary Measures

  • Surgical site infection
    • Time Frame: 30 days
    • The occurrence of surgical site infection according to CDC criteria

Participating in This Clinical Trial

Inclusion Criteria

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Basel, Switzerland
  • Provider of Information About this Clinical Study
    • Principal Investigator: Edin Mujagic, Edin Mujagic, MD – University Hospital, Basel, Switzerland
  • Overall Official(s)
    • Edin Mujagic, MD, Principal Investigator, University Hospital, Basel, Switzerland

References

Weber WP, Mujagic E, Zwahlen M, Bundi M, Hoffmann H, Soysal SD, Kraljević M, Delko T, von Strauss M, Iselin L, Da Silva RXS, Zeindler J, Rosenthal R, Misteli H, Kindler C, Müller P, Saccilotto R, Lugli AK, Kaufmann M, Gürke 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.

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, Kraljević 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.

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