The Effect of the Use of Sterile Transparent Film Dressing in Newborns

NCT05694390 | Completed

• 1 other identifier: YIU-M-CI-004
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

It is important that effective catheter fixation will reduce the risk of catheter unavailability for specific reasons and the incidence of catheter-related complications. The aim of this study was to determine the effect of sterile transparent film dressing and tape methods used in pe- ripheral intravenous catheter application in newborns on the duration of catheter stay and the development of catheter-related complications.

Conditions

Newborn; Peripheral Venous Catheterization

Outcome Measures

Primary Outcomes (3)

• The infiltration scale for infants

  The scale published by the Infusion Nurses Association was revised by Tofani et al. The adaptation of the scale to the newborns was carried out by Calikusu Incekar et al. The scale consists of 5 grades: 0, 1, 2, 3, 4 and is applied to babies under 4 kg. In this study, the infiltration scale was used to determine infiltration and extravasation. In addition to the scale items, the criteria of "Redness accompanied by a vesicle, tissue necrosis, and ulcer" were also considered based on the literature to determine extravasation.

  during catheter removal procedure

• The Phlebitis Scale

  The phlebitis scale published by the Infusion Nurses Society was used. The scale consists of 5 grades: 0, 1, 2, 3, 4.

  during catheter removal procedure

• Occlusion

  The nurse checked the infant's catheter site for occlusion.

  during catheter removal procedure

Study Arms (2)

Experimental group: The group applied sterile transparent film dressing

EXPERIMENTAL

The nurses in the unit were trained by the charge nurse of the clinic on catheter-related complications (infiltration, extravasation, phlebitis, and occlusion), the scales used in the study, and the use of sterile transparent film dressing. In the experimental group, a sterile transparent film dressing was used to fix the catheter and was monitored hourly until the catheter was removed.

Other: Use of sterile transparent film dressing

Control group: The group applied fixed with a tape (blaster)

NO INTERVENTION

The nurses in the unit were trained by the charge nurse of the clinic on catheter-related complications (infiltration, extravasation, phlebitis, and occlusion), the scales used in the study, and the use of sterile transparent film dressing. In the control group, the catheter was fixed with a tape (blaster), routinely used in the clinic, and was monitored hourly until the catheter was removed.

Interventions

Use of sterile transparent film dressing OTHER

The nurses in the unit were trained by the charge nurse of the clinic on catheter-related complications (infiltration, extravasation, phlebitis, and occlusion), the scales used in the study, and the use of sterile transparent film dressing. In the experimental group, a sterile transparent film dressing was used to fix the catheter and was monitored hourly until the catheter was removed. The infiltration scale for infants, , the criteria of extravasation (Redness accompanied by a vesicle, tissue necrosis, and ulcer), and The Phlebitis Scale were used to evaluate the catheter site.

Experimental group: The group applied sterile transparent film dressing

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• less than 4 kg (due to the infiltration scale criteria)
• PICV was inserted for the first time

You may not qualify if:

• existing catheter,
• who has a catheter other than PICV (PICC, umbilical catheter, etc.),
• sterile transparent film dressing, tape, babies with allergies to antiseptic solution and catheter,
• with immunodeficiency, and with skin problems that prevent catheter opening

Sponsors & Collaborators

• Yuksek Ihtisas Hospital: lead

Study Sites (1)

Yuksek Ihtisas University

Ankara, Turkey (Türkiye)

Location

Study Officials

• Suzan YILDIZ, PhD

  Istanbul University - Cerrahpasa

  PRINCIPAL INVESTIGATOR

• Yağmur GÜL, BSN

  Istanbul Florence Nightingale Hospital

  PRINCIPAL INVESTIGATOR

• Ozan UZUNHAN, MD

  Istanbul Florence Nightingale Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 22, 2022
• First Posted: January 23, 2023
• Study Start: February 1, 2019
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: January 23, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)