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

Not Applicable

Not yet recruiting

• Conditions: Neonatal Skin Conditions
• Interventions: Other: Hydrocolloid dressing; Other: Hypoallergenic Flexible

• Registration Number: NCT06246864
• Lead Sponsor: Ondokuz Mayıs University

Brief Summary

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.

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 Timeline

• Study First Submitted: 2024-01-30
• Study First Submitted QC: 2024-01-30
• Status Verified: 2024-02
• Study Start: 2024-02-05
• Study First Posted: 2024-02-07
• Last Update Submitted: 2024-02-07
• Last Update Posted: 2024-02-09
• Primary Completion: 2024-08-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hydrocolloid dressing group	Hydrocolloid dressing	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.
Hypoallergenic Flexible Patch group	Hypoallergenic Flexible	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.

Primary Outcome Measures

Name	Time	Method
Newborn Skin Condition Score	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.