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

NCT06246864 | Not Yet Recruiting

• 1 other identifier: Flaster
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Neonatal Skin Conditions

Keywords

premature; skin care; Hydrocolloid dressing; hypoallergenic patch

Outcome Measures

Primary Outcomes (1)

• Newborn Skin Condition Score

  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.

  The patch will be removed 24 hours after orogastric detection and a skin evaluation will be performed immediately.

Study Arms (2)

Hydrocolloid dressing group

EXPERIMENTAL

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.

Other: Hydrocolloid dressing

Hypoallergenic Flexible Patch group

ACTIVE COMPARATOR

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.

Other: Hypoallergenic Flexible

Interventions

Hydrocolloid dressing 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.

Hydrocolloid dressing group

Hypoallergenic Flexible 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.

Hypoallergenic Flexible Patch group

Eligibility Criteria

• Age: 32 Weeks - 36 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

MeSH Terms

Conditions

Premature Birth

Interventions

Bandages, Hydrocolloid

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Bandages; Equipment and Supplies

Central Study Contacts

Esra Tural Büyük, pHD

CONTACT

5052795196; esratural55@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: randomized control experimental trial

Study Record Dates

• First Submitted: January 30, 2024
• First Posted: February 7, 2024
• Study Start: February 5, 2024
• Primary Completion: August 31, 2024
• Study Completion: December 31, 2024
• Last Updated: February 9, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share