Drains and Surgical Site Infections

NCT03408782 | Completed

• 1 other identifier: ch10Weber
• Study Type: observational
• Target: 4,584
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Surgical Site Infection

Keywords

Surgical Site Infection; Surgical drains

Outcome Measures

Primary Outcomes (1)

• Surgical site infection

  The occurrence of surgical site infection according to CDC criteria

  30 days

Study Arms (2)

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

Insertion of drainage PROCEDURE

Drainage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Related Publications (2)

• 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.

  PMID: 28385346 BACKGROUND

• 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.

  PMID: 24885132 BACKGROUND

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Edin Mujagic, MD

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Edin Mujagic, MD

Study Record Dates

• First Submitted: January 17, 2018
• First Posted: January 24, 2018
• Study Start: February 22, 2013
• Primary Completion: August 31, 2015
• Study Completion: August 31, 2015
• Last Updated: January 24, 2018

Record last verified: 2018-01