Additional Circular Dressing Material

NCT06310694 | Completed

• 1 other identifier: EGE-HEM-SL-01
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nurse's Role

Keywords

peripheral cannulation; catheter related complications; infusions; intravenous; dressing; nursing

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (2)

Intervention Group (Elastane circular dressing on sterile transparent dressing)

EXPERIMENTAL

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. The 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.

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

Control group (fixation of PIVC with a sterile transparent dressing)

NO INTERVENTION

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. The 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

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.

Intervention Group (Elastane circular dressing on sterile transparent dressing)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals between the ages of 18-65
• Literate individuals
• Individuals who can communicate and fully focus
• Individuals without vision, hearing or perception problems

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ege University: lead

Study Sites (1)

Şeyma Turan

Turgutlu, Manisa, 45400, Turkey (Türkiye)

Location

Study Officials

• Leyla Khorshid, Prof. Dr.

  Ege University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: 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.

Study Record Dates

• First Submitted: February 16, 2024
• First Posted: March 15, 2024
• Study Start: April 27, 2023
• Primary Completion: September 30, 2023
• Study Completion: December 30, 2023
• Last Updated: March 15, 2024

Record last verified: 2024-03

Locations

TU (1)