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

Not Applicable

Completed

• Conditions: Newborn; Peripheral Venous Catheterization
• Interventions: Other: Use of sterile transparent film dressing

• Registration Number: NCT05694390
• Lead Sponsor: Yuksek Ihtisas Hospital

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.

Detailed Description

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.

Study Timeline

• Study Start: 2019-02-01
• Primary Completion: 2021-09-30
• Study Completion: 2021-09-30
• Study First Submitted: 2022-12-22
• Status Verified: 2023-01
• Study First Submitted QC: 2023-01-20
• Last Update Submitted: 2023-01-20
• Study First Posted: 2023-01-23
• Last Update Posted: 2023-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group: The group applied sterile transparent film dressing	Use of sterile transparent film dressing	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.

Primary Outcome Measures

Name	Time	Method
The Phlebitis Scale	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.
Occlusion	during catheter removal procedure	The nurse checked the infant's catheter site for occlusion.
The infiltration scale for infants	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.

Trial Locations

Locations (1)

Yuksek Ihtisas University; 🇹🇷 Ankara, Turkey