Drains and Surgical Site Infections

NCT ID: NCT03408782

Last Updated: 2018-01-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 4584 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-02-22
• Study Completion Date: 2015-08-31

Brief 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.

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.

Conditions

Surgical Site Infection

Study Design

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

Study Groups

No drainage

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

No interventions assigned to this group

Drainage

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

Insertion of drainage

Intervention Type: PROCEDURE

Interventions

Insertion of drainage

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Edin Mujagic

Edin Mujagic, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Edin Mujagic, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Basel, Switzerland

References

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.

Reference Type: BACKGROUND

PMID: 28385346 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24885132 (View on PubMed)

Other Identifiers

ch10Weber

Identifier Type: -

Identifier Source: org_study_id