Ignite Creation Date:
2025-12-24 @ 9:47 PM
Ignite Modification Date:
2026-01-10 @ 8:25 AM
Study NCT ID:
NCT04102332
Status:
COMPLETED
Last Update Posted:
2019-09-25
First Post:
2019-09-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safe Infusion Device in Reducing Occupational Exposure of Nurses
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2018-10-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-23', 'studyFirstSubmitDate': '2019-09-23', 'studyFirstSubmitQcDate': '2019-09-23', 'lastUpdatePostDateStruct': {'date': '2019-09-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Rate of contamination of nurses' gloves with cytotoxic products", 'timeFrame': 'day 1', 'description': '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).'}], 'secondaryOutcomes': [{'measure': "Quantitative contamination of nurses' gloves with cytotoxic products", 'timeFrame': 'day 1', 'description': 'The dosing assay allowed to identify a panel of 10 cytotoxic drugs (HPLC MS/MS).'}, {'measure': 'Costs', 'timeFrame': 'day 1', 'description': 'For each daily course performed in 2017 requiring the intravenous route, the necessary devices were estimated according to the two strategies'}, {'measure': 'Manufacturing time', 'timeFrame': 'day 1', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Antineoplastic Agents', 'Cancer', 'Drug administration', 'Infusion device', 'Occupational Exposure', 'Nursing'], 'conditions': ['Cancer']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nA 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.\n\nThe 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.\n\nDespite 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Nurses that have to manipulate drugs for chemotherapies and that meet risks of contamination were asked to paritipate at the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Protocols which contained at least one of the 10 drugs of the dosing assay\n* Protocols with at least one disconnection step.\n* 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.\n\nExclusion Criteria:\n\n\\- Drugs administrated with syringes (intravenously or subcutaneously) were not included because of the absence of impact of the SIDs on these modalities of administration.'}, 'identificationModule': {'nctId': 'NCT04102332', 'acronym': 'CONTAMOINS-1', 'briefTitle': 'Safe Infusion Device in Reducing Occupational Exposure of Nurses', 'organization': {'class': 'OTHER', 'fullName': 'Institut de Cancérologie de la Loire'}, 'officialTitle': 'Evaluation of a Safe Infusion Device in Reducing Occupational Exposure of Nurses to Antineoplastic Drugs: a Comparative Prospective Study. CONTAMOINS-1', 'orgStudyIdInfo': {'id': '2017-PH1'}, 'secondaryIdInfos': [{'id': 'IRBN522017/CHUSTE', 'type': 'OTHER', 'domain': "Comité d'Ethique du CHU de Saint-Etienne"}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Before arm', 'description': 'usual infusion practices (neutral solvent-purged infusers)'}, {'label': 'After arm', 'description': 'Safe Infusion Device', 'interventionNames': ['Device: Safe Infusion Device']}], 'interventions': [{'name': 'Safe Infusion Device', 'type': 'DEVICE', 'description': 'Safe infusion device is a different method than usual infusion practices (neutral solvent-purged infusers)', 'armGroupLabels': ['After arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '42270', 'city': 'Saint-Priest-en-Jarez', 'country': 'France', 'facility': 'Institut de Cancérologie Lucien Neuwirth', 'geoPoint': {'lat': 45.4739, 'lon': 4.37678}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut de Cancérologie de la Loire', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centre Hospitalier Lyon Sud', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}