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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06246864
Enrollment
60
Registered
2024-02-07
Start date
2024-02-05
Completion date
2024-12-31
Last updated
2024-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal Skin Conditions

Keywords

premature, skin care, Hydrocolloid dressing, hypoallergenic patch

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.

Interventions

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.

OTHERHypoallergenic 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.

Sponsors

Ondokuz Mayıs University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Intervention model description

randomized control experimental trial

Eligibility

Sex/Gender
ALL
Age
32 Weeks to 36 Weeks
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Newborn Skin Condition ScoreThe 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.

Contacts

Primary ContactEsra Tural Büyük, pHD
esratural55@gmail.com5052795196

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026