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The Effect of Surgical Incision Drep Use in Endotracheal Tube Fixation

The Effect of Surgical Incision Drep Use in Endotracheal Tube Fixation in Neonatal Preterm Infants: A Randomized Controlled Trial

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06832553
Enrollment
110
Registered
2025-02-18
Start date
2024-10-15
Completion date
2025-07-15
Last updated
2025-03-14

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

Conditions

Preterm

Keywords

preterm

Brief summary

It is aimed to minimise both unplanned extubation and skin damage with the surgical incision drep that we will use to fix the endotracheal tube in neonatal preterm infants and to reduce the complications that may develop due to these events. In addition, it is aimed to evaluate the relationship between these parameters by using devices measuring skin moisture, skin pH and Neonatal Skin Condition Assessment Scale in experimental and control groups.

Detailed description

The aim of this study is to investigate the effectiveness of surgical incision drape usage for securing endotracheal tubes in preterm neonates. The study will be conducted using a randomized controlled design, and participants will be divided into two groups: those using the surgical drape and those not using it. The population of the study will consist of preterm infants who are hospitalised in the neonatal intensive care unit of Batman Training and Research Hospital. Intubated preterm infants between 28-34 weeks will be included in the study regardless of gender difference. Research data will be collected by the following methods: Demographic information, Neonatal Skin Condition Rating Scale (NSCS), Skin Ph meter device and skin moisture meter device. Data will be collected every 24 hours during the intubation period. The results of the study are expected to provide important theoretical and practical contributions. The effects of parameters such as skin wounds that may occur due to endotracheal tube fixation in infants, unplanned extubation rates, skin pH and skin moisture at the site of intubation fixation will be compared between the surgical incision drep and the standard group. The research data will be analysed using IBM SPSS 27.0 Programme (Statistical Package for Social Sciences).

Interventions

OTHERsurgical incision drep

To compare the efficacy of surgical incision with silk plaster in ETT fixation.

Sponsors

Hasan Kalyoncu University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
28 Weeks to 34 Weeks
Healthy volunteers
Yes

Inclusion criteria

* Preterm infants between 28-34 weeks of gestation hospitalized in neonatal intensive care unit, * Intubated infants on invasive mechanical ventilators, * Babies who were orally intubated were included in the study.

Exclusion criteria

* Congenital skin condition, * With circulatory problems, * Congenital anomalies and metabolic disorders, * Small for gestational age (SGA) and large for gestational age (LGA), * Unplanned extubation taking place, * Babies intubated for less than 24 hours will be excluded from the study.

Design outcomes

Primary

MeasureTime frameDescription
demographic datathrough study completion, an average of 1 yearIt will consist of questions such as gestational week, birth weight, postnatal age, frequency of endotracheal tube re-fixation, reason for hospitalization, frequency of aspiration, mode of delivery, gender, phototherapy status, antibiotic status, sedative use, analgesic use, ventilator mode.

Secondary

MeasureTime frameDescription
skin ph meter and skin moisture meterthrough study completion, an average of 1 yearDuring the intubation period, skin pH and skin moisture meter data will be obtained from the experimental and control group patients every 24 hours at the intubation fixation site.

Other

MeasureTime frameDescription
Newborn Skin Condition Assessment Scalethrough study completion, an average of 1 yearData will be collected every 24 hours.The scale consists of three dimensions including dryness, redness and impaired skin integrity/peeling. The NSCS can be used in all newborns and a score between 3 and 9 is obtained. The lowest score of 3 indicates the best skin score, while the highest score of 9 indicates the worst skin score. skin wounds scores at the site of intubation tube fixation will be compared in experimental and control groups.
unplanned extubationthrough study completion, an average of 1 yearData will be collected and statistical values will be calculated when an unplanned extubation event occurs in the experimental and control group patients while the patient is intubated.

Countries

Turkey (Türkiye)

Contacts

Primary ContactBarış Çelik
c.celikbaris@gmail.com5424283452
Backup ContactAyla Yava
ayla.yava@hku.edu.tr05372419171

Outcome results

None listed

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