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

Primary Purpose

Newborn, Peripheral Venous Catheterization

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Use of sterile transparent film dressing
Sponsored by
Yuksek Ihtisas Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Newborn

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Yuksek Ihtisas University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental group: The group applied sterile transparent film dressing

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

Arm Description

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 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 22, 2022
Last Updated
January 20, 2023
Sponsor
Yuksek Ihtisas Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05694390
Brief Title
The Effect of the Use of Sterile Transparent Film Dressing in Newborns
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
September 30, 2021 (Actual)
Study Completion Date
September 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yuksek Ihtisas Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Newborn, Peripheral Venous Catheterization

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental group: The group applied sterile transparent film dressing
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group: The group applied fixed with a tape (blaster)
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Use of sterile transparent film dressing
Intervention Description
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 Outcome Measure Information:
Title
The infiltration scale for infants
Description
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.
Time Frame
during catheter removal procedure
Title
The Phlebitis Scale
Description
The phlebitis scale published by the Infusion Nurses Society was used. The scale consists of 5 grades: 0, 1, 2, 3, 4.
Time Frame
during catheter removal procedure
Title
Occlusion
Description
The nurse checked the infant's catheter site for occlusion.
Time Frame
during catheter removal procedure

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suzan YILDIZ, PhD
Organizational Affiliation
Istanbul University - Cerrahpasa (IUC)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yağmur GÜL, BSN
Organizational Affiliation
Istanbul Florence Nightingale Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ozan UZUNHAN, MD
Organizational Affiliation
Istanbul Florence Nightingale Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yuksek Ihtisas University
City
Ankara
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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