Safe Infusion Device in Reducing Occupational Exposure of Nurses (CONTAMOINS-1)

Evaluation of a Safe Infusion Device in Reducing Occupational Exposure of Nurses to Antineoplastic Drugs: a Comparative Prospective Study. CONTAMOINS-1

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.

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Device: Safe Infusion Device

Detailed Description

Despite the decreasing of environmental contamination throughout the anticancer drug circuit, the administration of chemotherapies remains at risk of occupational exposure for nurses. Many medical devices aim at securing administration, but none have been scientifically evaluated to verify the actual improvement.

A monocentric comparative before / after study was carried out in an oncology day hospital in order to evaluate the efficacy of Safe Infusion Devices in reducing drug exposure compared to usual perfusion practices (neutral solvent-purged infusers). The rate of nurses' gloves contamination was estimated. The eligible protocols must contain at least one disconnection step and one of the 10 drugs screened. To avoid false negatives, each sample of gloves was contaminated with a drop of topotecan. Association between contamination and other variables was investigated using a multivariate regression analysis.

The usual practice leaded to a rate of 58.3% of contaminated samples while Safe Infusion Devices to a rate of 15%: Safe Infusion Devices reduced the risk of gloves contamination by 84% in multivariate analysis (Odds ratio=0.16; 95% confidence interval=0.05-0.47; p<0.001). Topotecan was identified within 100% of the samples. Only one case of cross-contamination has occurred.

Despite the current practice of using neutral solvent-purged infusers, the occupational exposure remains high for nurses and Safe Infusion Devices significantly reduced this risk of exposure. However, glove contamination is only a surrogate endpoint. The results confirmed that the disconnection of empty bags resulted in occupational exposure. Except a contamination due to the leakage of a bag, no cross-contamination was detected. This validated the environmental quality of the cytotoxic drug circuit. Safe Infusion Devices were highly effective but did not completely eliminate exposure.

• Study Type: Observational
• Enrollment (Actual): 120

Contacts and Locations

Study Locations

• France
  • Saint-Priest-en-Jarez, France, 42270
    • Institut de Cancérologie Lucien Neuwirth

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-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.

Description

Inclusion Criteria:

• Protocols which contained at least one of the 10 drugs of the dosing assay
• Protocols with at least one disconnection step.
• Given the large number of eligible protocols, we favored those with the most concentrated products (CPM, PMX) to maximize the chance of detecting contamination and also to extend inclusions over a longer period.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Before arm; usual infusion practices (neutral solvent-purged infusers)
After arm; Safe Infusion Device	Device: Safe Infusion Device; Safe infusion device is a different method than usual infusion practices (neutral solvent-purged infusers)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantitative contamination of nurses' gloves with cytotoxic products	The dosing assay allowed to identify a panel of 10 cytotoxic drugs (HPLC MS/MS).	day 1
Costs	For each daily course performed in 2017 requiring the intravenous route, the necessary devices were estimated according to the two strategies	day 1
Manufacturing time	The manufacturing time was defined as the time elapsed between the time of passage in the cleanroom and the end of manufacturing of the first drug of the course.	day 1

Collaborators and Investigators

• Sponsor: Institut de Cancérologie de la Loire
• Collaborators: Centre Hospitalier Lyon Sud

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2017
• Primary Completion (Actual): October 1, 2018
• Study Completion (Actual): October 8, 2018

Study Registration Dates

• First Submitted: September 23, 2019
• First Submitted That Met QC Criteria: September 23, 2019
• First Posted (Actual): September 25, 2019

Study Record Updates

• Last Update Posted (Actual): September 25, 2019
• Last Update Submitted That Met QC Criteria: September 23, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Cancer; Nursing; Antineoplastic Agents; Occupational Exposure; Infusion device; Drug administration
• Other Study ID Numbers: 2017-PH1; IRBN522017/CHUSTE (Other Identifier: Comité d'Ethique du CHU de Saint-Etienne)

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