Drains and Surgical Site Infections

Completed

• Conditions: Surgical Site Infection
• Interventions: Procedure: Insertion of drainage

• Registration Number: NCT03408782
• Lead Sponsor: University Hospital, Basel, Switzerland

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.

Study Timeline

• Study Start: 2013-02-22
• Primary Completion: 2015-08-31
• Study Completion: 2015-08-31
• Status Verified: 2018-01
• Study First Submitted: 2018-01-17
• Study First Submitted QC: 2018-01-17
• Last Update Submitted: 2018-01-17
• Study First Posted: 2018-01-24
• Last Update Posted: 2018-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4584

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Drainage	Insertion of drainage	Those patients that underwent surgery and one or several drains were inserted at the end of the procedure.

Primary Outcome Measures

Name	Time	Method
Surgical site infection	30 days	The occurrence of surgical site infection according to CDC criteria