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

Institut de Cancérologie de la Loire

Status

Completed

Conditions

Cancer

Treatments

Device: Safe Infusion Device

Study type

Observational

Funder types

Other

Identifiers

NCT04102332

2017-PH1

IRBN522017/CHUSTE (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

120 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.