NCT03456635

Brief Summary

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

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
20,000

participants targeted

Target at P75+ for not_applicable surgery

Timeline
Completed

Started Jan 2017

Longer than P75 for not_applicable surgery

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 22, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 7, 2018

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2023

Completed
Last Updated

January 20, 2022

Status Verified

January 1, 2022

Enrollment Period

6 years

First QC Date

February 22, 2018

Last Update Submit

January 19, 2022

Conditions

Surgery

Keywords

antimicrobialprophylaxysCDSS

Outcome Measures

Primary Outcomes (1)

  • Adequacy rate of surgical antimicrobial prophylaxis

    Adequacy rate of surgical antimicrobial prophylaxis according to the internal guidelines

    baseline & 1 year

Secondary Outcomes (1)

  • Incidence of surgical site infections

    baseline & 1 year

Study Arms (2)

usual antimicrobial prophylaxys

NO INTERVENTION

standard of care: perioperative antimicrobial prophylaxis without computerized decision support system

guided antimicrobial prophylaxis

EXPERIMENTAL

perioperative antimicrobial prophylaxis guided by a computerized decision support system

Other: guided antimicrobial prophylaxis

Interventions

guided antimicrobial prophylaxisOTHER

During the intervention period, antimicrobial prophylaxis decisions will be guided by a computerized program

guided antimicrobial prophylaxis

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Patients \< 40 kgs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals of Geneva

Geneva, 1205, Switzerland

Location

Study Officials

  • Americo Agostinho, BSc

    Clinical nurse specialist

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Masking Details
unblinded
Purpose
SUPPORTIVE CARE
Intervention Model
SEQUENTIAL
Model Details: quasi-experimental study Time-series analysis, with a non-equivalent variable prospective Quality Improvement project
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Nurse Specialist

Study Record Dates

First Submitted

February 22, 2018

First Posted

March 7, 2018

Study Start

January 1, 2017

Primary Completion

December 31, 2022

Study Completion

July 31, 2023

Last Updated

January 20, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)