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

Ondokuz Mayıs University

Status: Not yet enrolling

Conditions: Neonatal Skin Conditions

Treatments: Other: Hypoallergenic Flexible; Other: Hydrocolloid dressing

Study type: Interventional

Funder types: Other

Identifiers

NCT06246864

Flaster

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 32 to 36 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Hydrocolloid dressing group

Experimental group

Description:

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.

Treatment:

Other: Hydrocolloid dressing

Hypoallergenic Flexible Patch group

Active Comparator group

Description:

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.

Treatment:

Other: Hypoallergenic Flexible