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

NCT ID: NCT05694390

Last Updated: 2023-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-01

Study Completion Date

2021-09-30

Brief Summary

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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

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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.

Conditions

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Newborn Peripheral Venous Catheterization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Experimental group: The group applied 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.

Group Type EXPERIMENTAL

Use of sterile transparent film dressing

Intervention Type 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.

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

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yuksek Ihtisas Hospital

OTHER

Sponsor Role lead

Responsible Party

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Mujde CALIKUSU Incekar

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Suzan YILDIZ, PhD

Role: PRINCIPAL_INVESTIGATOR

Istanbul University - Cerrahpasa

Yağmur GÜL, BSN

Role: PRINCIPAL_INVESTIGATOR

Istanbul Florence Nightingale Hospital

Ozan UZUNHAN, MD

Role: PRINCIPAL_INVESTIGATOR

Istanbul Florence Nightingale Hospital

Locations

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Yuksek Ihtisas University

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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YIU-M-CI-004

Identifier Type: -

Identifier Source: org_study_id

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