Clinical trial NCT04102332: Safe Infusion Device in Reducing Occupational Exposure of Nurses
Official title: Evaluation of a Safe Infusion Device in Reducing Occupational Exposure of Nurses to Antineoplastic Drugs: a Comparative Prospective Study. CONTAMOINS-1
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Keywords: Antineoplastic Agents
Cancer
Drug administration
Infusion device
Occupational Exposure
Nursing
Lead sponsor: Institut de Cancérologie de la Loire
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier Lyon Sud
First posted: 2019-09-25
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Rate of contamination of nurses' gloves with cytotoxic products
timeFrame: day 1
Secondary outcomes:
measure: Quantitative contamination of nurses' gloves with cytotoxic products
timeFrame: day 1
measure: Costs
timeFrame: day 1
measure: Manufacturing time
timeFrame: day 1
Other outcomes:
Locations:
city: Saint-Priest-en-Jarez
country: France
facility: Institut de Cancérologie Lucien Neuwirth
Study officials:
References: