NCT04102332

Brief Summary

Monocentric comparative before / after study to evaluate the efficacy of Safe Infusion Devices (SIDs) in reducing drug exposure to nurses compared to usual perfusion practices.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

December 12, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 8, 2018

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 23, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 25, 2019

Completed
Last Updated

September 25, 2019

Status Verified

September 1, 2019

Enrollment Period

10 months

First QC Date

September 23, 2019

Last Update Submit

September 23, 2019

Conditions

Cancer

Keywords

Antineoplastic AgentsCancerDrug administrationInfusion deviceOccupational ExposureNursing

Outcome Measures

Primary Outcomes (1)

  • Rate of contamination of nurses' gloves with cytotoxic products

    The statistical unit consists of a sample taken from all the gloves used for the administration of a daily course. The dosing assay allowed to identify a panel of 10 cytotoxic drugs (HPLC MS/MS).

    day 1

Secondary Outcomes (3)

  • Quantitative contamination of nurses' gloves with cytotoxic products

    day 1

  • Costs

    day 1

  • Manufacturing time

    day 1

Study Arms (2)

Before arm

usual infusion practices (neutral solvent-purged infusers)

After arm

Safe Infusion Device

Device: Safe Infusion Device

Interventions

Safe Infusion DeviceDEVICE

Safe infusion device is a different method than usual infusion practices (neutral solvent-purged infusers)

After arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Nurses that have to manipulate drugs for chemotherapies and that meet risks of contamination were asked to paritipate at the study.

You may qualify if:

  • Protocols which contained at least one of the 10 drugs of the dosing assay
  • Protocols with at least one disconnection step.

You may not qualify if:

  • \- Drugs administrated with syringes (intravenously or subcutaneously) were not included because of the absence of impact of the SIDs on these modalities of administration.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut de Cancérologie Lucien Neuwirth

Saint-Priest-en-Jarez, 42270, France

Location

MeSH Terms

Conditions

Neoplasms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2019

First Posted

September 25, 2019

Study Start

December 12, 2017

Primary Completion

October 1, 2018

Study Completion

October 8, 2018

Last Updated

September 25, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)