Effect of Different Materials Used in Orogastric Tube Removal on Skin Condition in Premature Babies

February 26, 2024 updated by: Hatice Uzşen, Ondokuz Mayıs University
While medical adhesives provide fixation of devices and catheters in neonatal intensive care, problems such as disruption of skin integrity are frequently encountered when removed. The study aims to compare the effectiveness of sunflower oil and silicone-based remover spray used during the removal of medical adhesives used in oragastric catheter fixation in preterm babies in the Neonatal Intensive Care Unit in preventing skin damage.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Use of materials such as an endotracheal tube, orogastric catheter, nasal cannula, and peripheral vein catheter, which are frequently used in neonatal intensive care.

Medical adhesives are needed for fixing. While medical adhesives provide fixation of devices and catheters in neonatal intensive care, problems such as disruption of skin integrity are frequently encountered when removed. Many materials are being tested and developed in clinics to reduce this risk.Skin barrier products minimize trauma in the removal of medical adhesives by creating a protective layer between the epidermis and the adhesive.

Silicone-based spray removers, one of the skin barrier products, are used in the entire patient population, including newborns.Silicone-based spray removers leave residue on the skin as they evaporate easily. doesn't let go. Since it does not contain alcohol, it does not cause pain. Sunflower oil is a traditional method for premature When used in baby massage applied to babies, it increases the weight gain and height growth of babies and reduces the morbidity rate.The study aims to compare the effectiveness of sunflower oil and silicone-based remover spray used during the removal of medical adhesives used in oragastric catheter fixation in preterm babies in the Neonatal Intensive Care Unit in preventing skin damage.

Study Type

Interventional

Enrollment (Actual)

86

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 Locations

  • Turkey
    • Atakum
      • Samsun, Atakum, Turkey, 55100
        • Hatice Uzşen

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

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Babies born between 32-36 gestational ages
  • Babies admitted to Neonatal Intensive Care
  • Babies who have not had medical adhesive tape applied to their lips before
  • Babies who do not have any skin diseases
  • Noninvasive Mechanical Ventilation or Free Ventilation in the Intensive Care Unit
  • Babies who need oxygen
  • Babies who do not have any obstacle to inserting an oragastric catheter

Exclusion Criteria:

  • Babies followed intubated in care
  • Babies with any skin disease
  • Babies with a disease that is not suitable for oragastric catheter insertion
  • Babies for whom medical adhesive should not be applied on the lips

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sunflower Oil Group
In the experimental group, patch removal will be performed using sunflower oil instead of silicone-based spray remover, which is the routine of the clinic. In children in the experimental group, the patch that has stuck to the baby's skin and needs to be changed is planned to be removed by applying sunflower oil on the patch.
Other: Sunflower oil
In the experimental group, patch removal will be performed using sunflower oil.
Active Comparator: Control group

In the clinic, the orogastric catheter is fixed above the lip (mustache area) with a hypoallergenic patch. In cases where the oral gastric catheter needs to be replaced or the adhesive patch needs to be renewed, hypoallergenic patches attached to the skin may cause tape abrasions and scratches on the newborn's skin when removed.Silicone-based spray removers are used to avoid causing injuries.

In the control group in the study, a silicone-based spray remover was used, which is the routine of the clinic, during the removal of hypoallergenic patches attached to the lip (moustache area) to fix the oragastric catheter.
Other: Slicone based spray
In the control group, clinical routine procedure will be used to remove the patch (silicone based spray.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neonatal Skin Condition Score
Time Frame: immediately after removing the patch of the orogastric tube and 1 hours later.

It is used to evaluate the skin condition of premature, healthy or sick newborns. The scale consists of three parts, each section has an evaluation section. These sections are respectively; dryness, erythema and disruption of skin integrity/peeling. Each section is scored between 1 and 3 on the scale developed as a three-point Likert scale.

is taking. The lowest score at the end of the scale is 3 and the highest score is 9. The higher the score, the worse the skin condition.
immediately after removing the patch of the orogastric tube and 1 hours later.

Collaborators and Investigators

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

Sponsor

Ondokuz Mayıs University

Investigators

  • Study Chair: Esra Tural Büyük, PhD, Ondokuz Mayıs University

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)

February 5, 2024

Primary Completion (Estimated)

June 5, 2024

Study Completion (Estimated)

August 5, 2024

Study Registration Dates

First Submitted

January 30, 2024

First Submitted That Met QC Criteria

February 26, 2024

First Posted (Actual)

February 28, 2024

Study Record Updates

Last Update Posted (Actual)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 26, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Orogastric Tube Removal

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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