The Effects of The Products Used In Nazogastric Tube Fixation

April 3, 2021 updated by: cagri covener ozcelik, Marmara University

Comparison of The Effects of The Products Used In Nazogastric Tube Fixation on Skin Integrity In Babies: Randomized Controlled Study

The present study was planned to compare the effect of products, used in the fixation of nasogastric tube, on skin integrity of 4-6 weeks infants hospitalized at neonatal and infant units. The hypothesis of the study is "Water-based barrier tape is more effective to protect skin integrity than hydrocolloid barrier tape."

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The study was planned as randomized controlled and experimental design to compare the efficiency of three different methods protecting skin deficiencies using adhesive products for 4-6 weeks infants. The universe of the study consisted of 4-6 weeks infants in neonatal and infants clinics of Giresun Women's and Children's Hospital between the dates of October 2020-2021. Power analysis was performed through G*Power (v3.1.7) programme in order to determine the number of the sample. At the beginning of the study, a pilot study was carried out with 15 participants from each of the groups and the effect size was calculated as d=0.672 regarding the assessment of skin condition scores and 108 participants in total should be included in the study as 36 participants for each groups in order to obtain 80% power in the level of α=0.05. Block randomization technique is applied in the study as a randomization method. "As for data collection "Infant desciption form" and "Neonatal Skin Condition Score Scale" is used. The scale is filled by two independent observer via double-blind method.

Study Type

Interventional

Enrollment (Anticipated)

108

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Çağrı Çövener Özçelik, PhD
  • Phone Number: 5773 +902167775700
  • Email: ccovener@gmail.com

Study Locations

  • Turkey
      • Giresun, Turkey
        • Recruiting
        • Giresun University Women and Children's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 weeks to 1 month (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All the 4-6 weeks infants including interventional process and without any skin diseases

Exclusion Criteria:

  • The infants receiving treatment without any interventional process
  • Those having a skin disease
  • Those infants having PICC and SVK catheters and do not meet the required criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Water-based barrier tape
The infants in experiment 1 group will be applied water-based barrier tape will be used to fix the nasogastric tube
Device: Water-based barrier tape
The infants in experiment 1 group will be applied water-based barrier tape. The area will be covered by water-based barrier tape to fix nasogastric tube and after waiting 1 minute for drying up it will be fastened by silk tape used in clinic. The silk tape will be 5 cm long and it will be changed in every 24 hours. Following the removal of silk tape on the water-based barrier tape, the skin integrity of the infants will be evaluated through "Neonatal Skin Condition Score Scale" and the score will be recorded in the chart. Water-based barrier tape will be applied to the area every time the plaster will be changed and current skin condition score will be noted to the chart.
Experimental: Hydrocolloid barrier tape
The infants in experiment 2 group, hydrocolloid barrier tape will be used to fix the nasogastric tube.
Device: Hydrocolloid barrier tape
As for experiment 2 group, hydrocolloid barrier tape will be used to fix the nasogastric tube. The hydrocolloid barrier tape, which was cut and shaped appropriately beforehand, will be applied to the area in order to stabilize the nasogastric tube and the tube will be stabilized with silk tape used in clinic. The silk tape will be 5 cm long and it will be changed in every 24 hours. Following the removal of silk tape on the hydrocolloid barrier tape, the skin integrity of the infants will be evaluated through "Neonatal Skin Condition Score Scale" . Since the hydrocolloid barrier tape can stay on the skin for 7 days and be transparent, the assessment of skin condition will be realized for 7 days and noted down to the chart.
Active Comparator: Adhesive product
The silk plaster used in clinic routinely will be used for control group infants to fix the nasogastric tube.
Device: Silk tape
The silk tape used in clinic routinely will be used for control group infants to fix the nasogastric tube without any barrier. The silk tape will be 5cm long and it will be changed in every 24 hours. Following the removal of silk tape, the skin integrity of the infants will be evaluated through "Neonatal Skin Condition Score Scale" and the score will be recorded in the chart.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Water-based barrier tape
Time Frame: 24 hours
To evaluate the skin integrity of the infants following the removal of silk adhesive from water-based barrier tape
24 hours
Hydrocolloid barrier tape
Time Frame: 24 hours
To evaluate the skin integrity of the infants following the removal of silk adhesive from hydrocolloid barrier tape
24 hours
Adhesive tape
Time Frame: 24 hours
To evaluate the skin integrity of the infants following the removal of silk adhesive from infants skin without any barrier tape
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marmara University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 2, 2020

Primary Completion (Anticipated)

October 2, 2021

Study Completion (Anticipated)

October 2, 2021

Study Registration Dates

First Submitted

March 15, 2021

First Submitted That Met QC Criteria

March 15, 2021

First Posted (Actual)

March 17, 2021

Study Record Updates

Last Update Posted (Actual)

April 8, 2021

Last Update Submitted That Met QC Criteria

April 3, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 87982892-929

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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