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

Not Applicable

Active, not recruiting

• Conditions: Neonatal Skin Conditions
• Interventions: Other: Sunflower oil; Other: Slicone based spray

• Registration Number: NCT06280326
• Lead Sponsor: Ondokuz Mayıs University

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.

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 Timeline

• Study First Submitted: 2024-01-30
• Status Verified: 2024-02
• Study Start: 2024-02-05
• Study First Submitted QC: 2024-02-26
• Last Update Submitted: 2024-02-26
• Study First Posted: 2024-02-28
• Last Update Posted: 2024-02-28
• Primary Completion: 2024-06-05
• Study Completion: 2024-08-05

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 86

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sunflower Oil Group	Sunflower oil	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.
Control group	Slicone based spray	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.

Primary Outcome Measures

Name	Time	Method
Neonatal Skin Condition Score	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.

Trial Locations

Locations (1)

Hatice Uzşen; 🇹🇷 Samsun, Atakum, Turkey