Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-25 @ 11:55 PM
Study NCT ID:
NCT06310694
Status:
COMPLETED
Last Update Posted:
2024-03-15
First Post:
2024-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Additional Circular Dressing Material
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'In our study, a comparison was made of PIVCs applied to patients in the control (fixation of PIVC with a sterile transparent dressing) and intervention (fixation of PIVC with a sterile transparent dressing and application of an elastane circular dressing on it) groups.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 91}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-04-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2023-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-07', 'studyFirstSubmitDate': '2024-02-16', 'studyFirstSubmitQcDate': '2024-03-07', 'lastUpdatePostDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Skin Penetration Difficulty Rating Scale', 'timeFrame': 'four months', 'description': 'The Numerical Rating Scale was used by the investigator who performed the peripheral intravenous catheterization attempt to evaluate the severity of difficulty penetrating the skin. It is a scale with numbers from 1 to 10, with 1 (easy) on one end and 10 (very difficult) on the other end. After PIVC application, the difficulty of penetrating the skin during catheter insertion was evaluated by the researcher, scoring between 1 and 10.'}, {'measure': 'Visual Infusion Phlebitis Diagnostic Scale', 'timeFrame': 'four months', 'description': 'Visual Infusion Phlebitis Diagnosis Scale includes grading steps and the symptoms of phlebitis seen at each stage in case of observation of the catheter for possible risks while applying treatment with a peripheral intravenous catheter or in case of phlebitis development. On this scale, symptoms of phlebitis such as redness, pain, swelling, fever and stiffness are rated from 1 to 5.'}, {'measure': 'Infiltration Rating Scale', 'timeFrame': 'four months', 'description': 'The infiltration rating scale is used to determine the development and extent of infiltration. On the infiltration scale, infiltration development is graded between 0 and 4 points.'}, {'measure': 'Data Collection Form for the Patient Who Had a Peripheral Intravenous Catheter', 'timeFrame': 'four months', 'description': "In this form, information such as the patient's age, gender, weight, height, BMI (Body Mass Index), diagnosis, chronic disease, date and time of PIVC application, date and time of PIVC termination, reason for PIVC termination, and the region where PIVC was applied were recorded."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['peripheral cannulation', 'catheter related complications', 'infusions', 'intravenous', 'dressing', 'nursing'], 'conditions': ["Nurse's Role"]}, 'descriptionModule': {'briefSummary': 'The study was conducted to determine the effect of fixing peripheral intravenous catheter (PIVC) with additional circular dressing material on the duration of PIVC stay and complications related to peripheral intravenous catheterization. In our study, a comparison was made of PIVCs applied to patients in the control (fixation of PIVC with a sterile transparent dressing) and intervention (fixation of PIVC with a sterile transparent dressing and application of an elastane circular dressing on it) groups in a public hospital in Turkey. All-cause PIVC failure was significantly higher in the intervention group (70.2%) compared to the control group (45.5%). It has been determined that fixing the PIVC with additional circular dressing material prolongs the duration of PIVC stay at the site.', 'detailedDescription': 'This study was conducted as a randomized controlled study to determine the effect of fixing the peripheral intravenous catheter (PIVC) with additional circular dressing material on the duration of stay of the peripheral intravenous catheter and complications related to peripheral intravenous catheterization. In our study, a comparison was made of PIVCs applied to patients in the control (fixation of PIVC with a sterile transparent dressing) and intervention (fixation of PIVC with a sterile transparent dressing and application of an elastane circular dressing on it) groups in a public hospital in Turkey. In our study, PIVC failure was defined as PIVC removal before the end of treatment due to phlebitis, infiltration, accidental dislodgement, occlusion, and leakage. A total of 91 (47 intervention, 44 control) participants were included in the study between April 2023 and September 2023. All-cause PIVC failure was significantly higher in the intervention group (70.2%) compared to the control group (45.5%). It was determined that fixing the PIVC with additional circular dressing material prolongs the duration of PIVC stay at the site. It is recommended that this study be conducted with a different patient population and multicenter.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\n* Individuals between the ages of 18-65\n* Literate individuals\n* Individuals who can communicate and fully focus\n* Individuals without vision, hearing or perception problems\n\nExclusion criteria\n\n* Individuals hospitalized for less than 72 hours\n* Individuals with edema degree 2 and above\n* Individuals receiving Total Parenteral Nutrition, colloid, blood products\n* Individuals with a BMI level of 29.9 and above (obese)'}, 'identificationModule': {'nctId': 'NCT06310694', 'briefTitle': 'Additional Circular Dressing Material', 'organization': {'class': 'OTHER', 'fullName': 'Ege University'}, 'officialTitle': 'Does Fixing Peripheral Intravenous Catheter With Additional Circular Dressing Material Reduce PIVC Failure And Complications? A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'EGE-HEM-SL-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Group (Elastane circular dressing on sterile transparent dressing)', 'description': 'A peripheral intravenous catheter was placed by following all the steps applied to the control group. A circular dressing made of elastane material was placed on the patients in the intervention group on a sterile transparent dressing to provide additional fixation on the peripheral intravenous catheter. There is no need to remove additional circular dressings during intravenous therapy.\n\nThe peripheral intravenous catheter was monitored for 72 hours with 8-hour observations. Peripheral intravenous catheter was evaluated for infiltration, phlebitis, pain, obstruction, dressing stability, and leakage.', 'interventionNames': ['Combination Product: intervention group (Elastane circular dressing on sterile transparent dressing)']}, {'type': 'NO_INTERVENTION', 'label': 'Control group (fixation of PIVC with a sterile transparent dressing)', 'description': "Peripheral intravenous catheter application was performed by the researcher in accordance with all steps. In the study, only patients who received a 20-gauge peripheral intravenous catheter were followed. The patient's peripheral intravenous catheter was fixed by the researcher with a sterile transparent dressing.\n\nThe peripheral intravenous catheter was monitored for 72 hours with 8-hour observations. Peripheral intravenous catheter was evaluated for infiltration, phlebitis, pain, obstruction, dressing stability, and leakage."}], 'interventions': [{'name': 'intervention group (Elastane circular dressing on sterile transparent dressing)', 'type': 'COMBINATION_PRODUCT', 'description': 'A circular dressing made of elastane material was placed on the patients in the intervention group on a sterile transparent dressing to provide additional fixation on the peripheral intravenous catheter.', 'armGroupLabels': ['Intervention Group (Elastane circular dressing on sterile transparent dressing)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45400', 'city': 'Turgutlu', 'state': 'Manisa', 'country': 'Turkey (Türkiye)', 'facility': 'Şeyma Turan', 'geoPoint': {'lat': 38.49533, 'lon': 27.6997}}], 'overallOfficials': [{'name': 'Leyla Khorshid, Prof. Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ege University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ege University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Şeyma Turan', 'investigatorAffiliation': 'Ege University'}}}}