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

Newborn Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05694390
• Other study ID #: YIU-M-CI-004
• Status: Completed
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: September 30, 2021

Study information

• Verified date: January 2023
• Source: Yuksek Ihtisas Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: September 30, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Infertility
• Newborn
• Peripheral Venous Catheterization

Intervention

Other:
• 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. 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.

Locations

Country	Name	City	State
Turkey	Yuksek Ihtisas University	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Yuksek Ihtisas Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Occlusion	The nurse checked the infant's catheter site for occlusion.	during catheter removal procedure