Skip to main content
OpenTrials
Completed

NCT Number: NCT05694390

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Newborn Peripheral Venous Catheterization

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yuksek Ihtisas University

Ankara, Turkey (Türkiye)

About this study

It has been reported that effective catheter fixation will reduce the risk of catheter unavailability for specific reasons and the incidence of catheter-related complications. Intravenous cannulas are usually fixed with a thin board, a bandage, and tape. There is no standard way of using PIVC dressings in Turkey. After the catheter is inserted into the vein, gauze and a blaster, sterile transparent dressing materials, or just a blaster, are used to prevent contact of the fixed part and the area of intervention with the external environment. Transparent dressing used for catheter fixation contribute to a more comfortable evaluation of the catheter entry site. It has been suggested that the use of transparent film dressing may be effective in preventing and early detection of catheter-related complications. Moreover, it was concluded that due to the short duration of the procedure, it reduced the cost of manpower, and nurses could devote more time to other patients.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. The infiltration scale for infants

    Time frame: during catheter removal procedure

    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.

  2. The Phlebitis Scale

    Time frame: during catheter removal procedure

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

  3. Occlusion

    Time frame: during catheter removal procedure

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

Sponsors and collaborators

Lead sponsor

Yuksek Ihtisas Hospital

Other

Registry information

Official study title

The Effect of the Use of Sterile Transparent Film Dressing on the Duration of Catheter Stay and the Development of Catheter-Related Complications in Newborns

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jan 23, 2023
Registry last updated
Jan 23, 2023

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.