Evaluation of the Effects on the Skin of Different Materials Used in Orogastric Tube Detection in Premature Babies

February 7, 2024 updated by: Esra TURAL BUYUK, Ondokuz Mayıs University

While medical adhesives provide fixation of devices and catheters in neonatal intensive care, they can cause disruption of skin integrity when removed. Therefore, when detecting medical devices, it is important to choose products that will not harm babies' skin and to use different occlusive dressings (polymer foams, hydrogel dressings, hydrocolloid dressings).

This study aims to compare the effectiveness of different types of patches (Hydrocolloid dressing and Hypoallergenic Flexible Patch) used in the detection of oragastric catheter (OG) in preterm babies hospitalized in the neonatal intensive care unit in preventing skin damage.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Many interventions are applied to premature babies in neonatal intensive care units due to the developing technologies in recent years. Babies in neonatal intensive care need many devices to maintain their vital functions and monitor the treatment process. The medical adhesive materials to be selected are important in determining the medical devices used in neonatal intensive care units, especially premature babies.

This study aims to compare the effectiveness of different types of patches (Hydrocolloid dressing and Hypoallergenic Flexible Patch) used in the detection of oragastric catheter (OG) in preterm babies hospitalized in the neonatal intensive care unit in preventing skin damage.

Study Type

Interventional

Enrollment (Estimated)

60

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

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

No

Description

Inclusion Criteria:

  • A newborn is a baby born between 32-36 weeks of gestation
  • No medical adhesive tape should be applied to the newborn's lips beforehand.
  • The newborn does not have any skin diseases
  • OG will be inserted into the newborn for the first time
  • Having a newborn receiving respiratory support with non-invasive mechanical ventilation, hood or free oxygen

Exclusion Criteria:

  • The newborn is not a baby born between 32-36 weeks of gestation
  • Applying medical adhesive tape on the newborn's lips beforehand
  • The newborn has any skin disease
  • OG has been inserted into the newborn before and detected.
  • Supporting and detecting the newborn's breathing by intubating it

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: Hydrocolloid dressing group
The premature baby's Oragastric tube will be fixed using a hydrocollaid dressing. Orogastric fixation will not be changed for 24 days. After 24 hours, the fixed patch will be removed using a silicone-based spray remover.
Other: Hydrocolloid dressing
After the oral gastric tube is placed on the premature baby and fixed with a Hydrocolloid dressing, the fixed patch will be removed after 24 hours using a silicone-based spray remover.
Active Comparator: Hypoallergenic Flexible Patch group
Oragastric tube of premature baby Hypoallergenic Flexible Patch will be detected using . Orogastric fixation will not be changed for 24 days. After 24 hours, the fixed patch will be removed using a silicone-based spray remover.
Other: Hypoallergenic Flexible
After the oral gastric tube is placed on the premature baby and fixed with a hypoallergenic flexible patch, the fixed patch will be removed after 24 hours using a silicone-based spray remover.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Newborn Skin Condition Score
Time Frame: The patch will be removed 24 hours after orogastric detection and a skin evaluation will be performed immediately.
NSCS allows evaluation of the newborn's skin condition. It evaluates skin dryness, redness and integrity, which are the basic characteristics of the newborn's skin. The scale consists of three parameters.
The patch will be removed 24 hours after orogastric detection and a skin evaluation will be performed immediately.

Collaborators and Investigators

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

Sponsor

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 (Estimated)

February 5, 2024

Primary Completion (Estimated)

August 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

January 30, 2024

First Submitted That Met QC Criteria

January 30, 2024

First Posted (Actual)

February 7, 2024

Study Record Updates

Last Update Posted (Estimated)

February 9, 2024

Last Update Submitted That Met QC Criteria

February 7, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Flaster

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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