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

NCT06280326 | Active Not Recruiting

• 1 other identifier: Orogastric Tube Removal
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neonatal Skin Conditions

Keywords

neonatal; skin care; sunflower; preterm; slicone based spray

Outcome Measures

Primary Outcomes (1)

• Neonatal Skin Condition Score

  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.

Study Arms (2)

Sunflower Oil Group

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

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

Interventions

Sunflower oil OTHER

In the experimental group, patch removal will be performed using sunflower oil.

Sunflower Oil Group

Slicone based spray OTHER

In the control group, clinical routine procedure will be used to remove the patch (silicone based spray.

Control group

Eligibility Criteria

• Age: 32 Weeks - 36 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

Study Sites (1)

Hatice Uzşen

Samsun, Atakum, 55100, Turkey (Türkiye)

Location

Related Publications (1)

• Sahin B, Buyuk ET, Uzsen H, Koyun M, Karal FI. Effect of different materials used in the removal of orogastric catheter adhesive on the skin in premature babies in Turkey. J Pediatr Nurs. 2024 Sep-Oct;78:e117-e123. doi: 10.1016/j.pedn.2024.06.026. Epub 2024 Jul 8.

  PMID: 38971633 DERIVED

MeSH Terms

Conditions

Premature Birth

Interventions

Sunflower Oil

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Plant Oils; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• Esra Tural Büyük, PhD

  Ondokuz Mayıs University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, PHD

Model Details: Randomized controlled experimental trial

Study Record Dates

• First Submitted: January 30, 2024
• First Posted: February 28, 2024
• Study Start: February 5, 2024
• Primary Completion: June 5, 2024
• Study Completion: August 5, 2024
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)