NCT Number: NCT03408782
Drains and Surgical Site Infections
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.
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Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Primary outcomes
-
Surgical site infection
Time frame: 30 days
The occurrence of surgical site infection according to CDC criteria
Sponsors and collaborators
Lead sponsor
University Hospital, Basel, Switzerland
Other
Registry information
Official study title
The Association of Surgical Drains With the Risk of Surgical Site Infection - a Prospective Observational Study
Important dates
- Study start
- 2013
- Primary completion
- 2015
- Study completion
- 2015
- First posted
- Jan 24, 2018
- Registry last updated
- Jan 24, 2018
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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