Improving Perioperative Antimicrobial Prophylaxis by the Use of a Computerized Decision Support System (eSATP)

January 19, 2022 updated by: Américo Agostinho, University Hospital, Geneva
To evaluate the impact of using a computerized decision program on the adequacy of the perioperative antimicrobial prophylaxis

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Detailed Description

Adequacy rate of surgical antimicrobial prophylaxis, helped by a computerized decision support system, according to the internal guidelines considering the aspects: drug choice, dosing, timing, and re-dosing

Study Type

Interventional

Enrollment (Anticipated)

20000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Geneva, Switzerland, 1205
        • University Hospitals of Geneva

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All elective & emergency surgeries done by neurosurgery, orthopaedics, cardiovascular and digestive specialties made at University Hospitals of Geneva

Exclusion Criteria:

  • Patients < 40 kgs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: usual antimicrobial prophylaxys
standard of care: perioperative antimicrobial prophylaxis without computerized decision support system
Experimental: guided antimicrobial prophylaxis
perioperative antimicrobial prophylaxis guided by a computerized decision support system
Other: guided antimicrobial prophylaxis
During the intervention period, antimicrobial prophylaxis decisions will be guided by a computerized program

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adequacy rate of surgical antimicrobial prophylaxis
Time Frame: baseline & 1 year
Adequacy rate of surgical antimicrobial prophylaxis according to the internal guidelines
baseline & 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of surgical site infections
Time Frame: baseline & 1 year
Incidence of surgical site infections in subgroups: hip & knee, colon & rectum, lumbar neurosurgeries and heart surgeries
baseline & 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Geneva

Collaborators

University of Sao Paulo
Universidade do Porto

Investigators

  • Principal Investigator: Americo Agostinho, BSc, Clinical nurse specialist

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

July 31, 2023

Study Registration Dates

First Submitted

February 22, 2018

First Submitted That Met QC Criteria

February 28, 2018

First Posted (Actual)

March 7, 2018

Study Record Updates

Last Update Posted (Actual)

January 20, 2022

Last Update Submitted That Met QC Criteria

January 19, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-01881

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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