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NCT Number: NCT06310694

Additional Circular Dressing Material

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.

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Key information

Conditions

Nurse's Role

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Şeyma Turan

Turgutlu, Manisa, 45400, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

intervention group (Elastane circular dressing on sterile transparent dressing)

Combination Product

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.

Primary outcomes

  1. Skin Penetration Difficulty Rating Scale

    Time frame: four months

    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.

  2. Visual Infusion Phlebitis Diagnostic Scale

    Time frame: four months

    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.

  3. Infiltration Rating Scale

    Time frame: four months

    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.

  4. Data Collection Form for the Patient Who Had a Peripheral Intravenous Catheter

    Time frame: four months

    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.

Sponsors and collaborators

Lead sponsor

Ege University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 15, 2024
Registry last updated
Mar 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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