Additional Circular Dressing Material

Nurse's Role Clinical Trial

Official title:

Does Fixing Peripheral Intravenous Catheter With Additional Circular Dressing Material Reduce PIVC Failure And Complications? A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06310694
• Other study ID #: EGE-HEM-SL-01
• Status: Completed
• Phase: N/A
• Start date: April 27, 2023
• Est. completion date: December 30, 2023

Study information

• Verified date: March 2024
• Source: Ege University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: December 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion criteria

• Individuals between the ages of 18-65
• Literate individuals
• Individuals who can communicate and fully focus
• Individuals without vision, hearing or perception problems Exclusion criteria
• Individuals hospitalized for less than 72 hours
• Individuals with edema degree 2 and above
• Individuals receiving Total Parenteral Nutrition, colloid, blood products
• Individuals with a BMI level of 29.9 and above (obese)

Related Conditions & MeSH terms

• Nurse's Role

Intervention

Combination Product:
• intervention group (Elastane circular dressing on sterile transparent dressing)
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.

Locations

Country	Name	City	State
Turkey	Seyma Turan	Turgutlu	Manisa

Sponsors (1)

Lead Sponsor	Collaborator
Ege University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Skin Penetration Difficulty Rating Scale	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.	four months
Primary	Visual Infusion Phlebitis Diagnostic Scale	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.	four months
Primary	Infiltration Rating Scale	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.	four months
Primary	Data Collection Form for the Patient Who Had a Peripheral Intravenous Catheter	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.	four months