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

NCT ID: NCT06280326

Last Updated: 2024-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-05

Study Completion Date

2024-08-05

Brief Summary

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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

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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.

Conditions

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Neonatal Skin Conditions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled experimental trial
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Sunflower oil

Intervention Type OTHER

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

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.

Group Type ACTIVE_COMPARATOR

Slicone based spray

Intervention Type OTHER

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

Interventions

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Sunflower oil

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

Intervention Type OTHER

Slicone based spray

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

32 Weeks

Maximum Eligible Age

36 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ondokuz Mayıs University

OTHER

Sponsor Role lead

Responsible Party

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Hatice Uzşen

Principal Investigator, PHD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Esra Tural Büyük, PhD

Role: STUDY_CHAIR

Ondokuz Mayıs University

Locations

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Hatice Uzşen

Samsun, Atakum, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type DERIVED
PMID: 38971633 (View on PubMed)

Other Identifiers

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Orogastric Tube Removal

Identifier Type: -

Identifier Source: org_study_id

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