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SuspendedNCT03456635eSATPUpdated Jan 20, 2022

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

An interventional study of guided antimicrobial prophylaxis in Surgery, sponsored by University Hospital, Geneva. Suspended at 1 site in Switzerland. Per ClinicalTrials.gov, last updated 2022-01-20.

Sponsored by University Hospital, Geneva · Not applicable, Interventional, and Supportive care

Why this study was suspended
Due to COVID
Phase
Not applicable
Study type
Interventional
Enrollment
20,000
Allocation
Non-randomized
Sex
All
01

Study summary

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

Read the 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

02

Conditions studied

  • Surgery

Keywords

  • antimicrobial
  • prophylaxys
  • CDSS
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
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

Exclusion Criteria:

  • Patients \< 40 kgs
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
20,000 participants (estimated)

Study arms

  • 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

Interventions

  • Otherguided antimicrobial prophylaxis

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

05

What researchers measure

Primary outcomes

  1. Adequacy rate of surgical antimicrobial prophylaxis

    Adequacy rate of surgical antimicrobial prophylaxis according to the internal guidelines

    Time frame: baseline & 1 year

Secondary outcomes

  1. Incidence of surgical site infections

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

    Time frame: baseline & 1 year

06

Study locations

1 site
  • University Hospitals of Geneva
    Geneva, 1205, Switzerland
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03456635
Lead sponsor
University Hospital, Geneva
Collaborators
Universidade do Porto, University of Sao Paulo
Responsible party
Américo Agostinho (Clinical Nurse Specialist, University Hospital, Geneva) — Principal investigator
First posted
Mar 7, 2018
Start date
Jan 1, 2017
Primary completion
Dec 31, 2022 (estimated)
Completion
Jul 31, 2023 (estimated)
Last update
Jan 20, 2022

Study contacts

Americo Agostinho, BSc
principal investigator · Clinical nurse specialist

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is suspended, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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