Drains and Surgical Site Infections

Surgical Site Infection Clinical Trial

Official title:

The Association of Surgical Drains With the Risk of Surgical Site Infection - a Prospective Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03408782
• Other study ID #: ch10Weber
• Status: Completed
• Phase: N/A
• First received: January 17, 2018
• Last updated: January 17, 2018
• Start date: February 22, 2013
• Est. completion date: August 31, 2015

Study information

• Verified date: January 2018
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4584
• Est. completion date: August 31, 2015
• Est. primary completion date: August 31, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Surgical Site Infection
• Surgical Wound Infection

Intervention

Procedure:
• Insertion of drainage

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

References & Publications (2)

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. — View Citation

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, 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgical site infection	The occurrence of surgical site infection according to CDC criteria	30 days