Safe Infusion Device in Reducing Occupational Exposure of Nurses

Cancer Clinical Trial

— CONTAMOINS-1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04102332
• Other study ID #: 2017-PH1
• Secondary ID: IRBN522017/CHUST
• Status: Completed
• Start date: December 12, 2017
• Est. completion date: October 8, 2018

Study information

• Verified date: September 2019
• Source: Institut de Cancérologie de la Loire
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: October 8, 2018
• Est. primary completion date: October 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer

Intervention

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

Locations

Country	Name	City	State
France	Institut de Cancérologie Lucien Neuwirth	Saint-Priest-en-Jarez

Sponsors (2)

Lead Sponsor	Collaborator
Institut de Cancérologie de la Loire	Centre Hospitalier Lyon Sud

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Costs	For each daily course performed in 2017 requiring the intravenous route, the necessary devices were estimated according to the two strategies	day 1
Secondary	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