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

Sponsor
University Hospital, Geneva (Other)
Overall Status
Suspended
CT.gov ID
NCT03456635
Collaborator
Universidade do Porto (Other), University of Sao Paulo (Other)
20,000
Enrollment
1
Location
2
Arms
78.9
Anticipated Duration (Months)
253.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To evaluate the impact of using a computerized decision program on the adequacy of the perioperative antimicrobial prophylaxis

Condition or Disease Intervention/Treatment Phase
  • Other: guided antimicrobial prophylaxis
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
20000 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Intervention Model Description:
quasi-experimental study Time-series analysis, with a non-equivalent variable prospective Quality Improvement projectquasi-experimental study Time-series analysis, with a non-equivalent variable prospective Quality Improvement project
Masking:
None (Open Label)
Masking Description:
unblinded
Primary Purpose:
Supportive Care
Official Title:
Improving Perioperative Antimicrobial Prophylaxis by the Use of a Computerized Decision Support System
Actual Study Start Date :
Jan 1, 2017
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Jul 31, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Adequacy rate of surgical antimicrobial prophylaxis [baseline & 1 year]

    Adequacy rate of surgical antimicrobial prophylaxis according to the internal guidelines

Secondary Outcome Measures

  1. Incidence of surgical site infections [baseline & 1 year]

    Incidence of surgical site infections in subgroups: hip & knee, colon & rectum, lumbar neurosurgeries and heart surgeries

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospitals of Geneva Geneva Switzerland 1205

Sponsors and Collaborators

  • University Hospital, Geneva
  • Universidade do Porto
  • University of Sao Paulo

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Américo Agostinho, Clinical Nurse Specialist, University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT03456635
Other Study ID Numbers:
  • 2016-01881
First Posted:
Mar 7, 2018
Last Update Posted:
Jan 20, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Américo Agostinho, Clinical Nurse Specialist, University Hospital, Geneva
antimicrobial
prophylaxys
CDSS
Additional relevant MeSH terms:
Anti-Infective Agents
Anti-Bacterial Agents

Study Results

No Results Posted as of Jan 20, 2022