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

NCT ID: NCT06246864

Last Updated: 2024-02-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-05
• Study Completion Date: 2024-12-31

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.

Conditions

Neonatal Skin Conditions

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Hydrocolloid dressing group

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.

Group Type: EXPERIMENTAL

Hydrocolloid dressing

Intervention Type: OTHER

After the oral gastric tube is placed on the premature baby and fixed with a Hydrocolloid dressing, the fixed patch will be removed after 24 hours using a silicone-based spray remover.

Hypoallergenic Flexible Patch group

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.

Group Type: ACTIVE_COMPARATOR

Hypoallergenic Flexible

Intervention Type: OTHER

After the oral gastric tube is placed on the premature baby and fixed with a hypoallergenic flexible patch, the fixed patch will be removed after 24 hours using a silicone-based spray remover.

Interventions

Hydrocolloid dressing

After the oral gastric tube is placed on the premature baby and fixed with a Hydrocolloid dressing, the fixed patch will be removed after 24 hours using a silicone-based spray remover.

Intervention Type: OTHER

Hypoallergenic Flexible

After the oral gastric tube is placed on the premature baby and fixed with a hypoallergenic flexible patch, the fixed patch will be removed after 24 hours using a silicone-based spray remover.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 32 Weeks
• Maximum Eligible Age: 36 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ondokuz Mayıs University

OTHER

Sponsor Role: lead

Responsible Party

Esra TURAL BUYUK

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Esra Tural Büyük, pHD

Role: CONTACT

esratural55@gmail.com

5052795196

Other Identifiers

Flaster

Identifier Type: -

Identifier Source: org_study_id