The Effect of Surgical Incision Drep Use in Endotracheal Tube Fixation

March 11, 2025 updated by: Barış Çelik, Hasan Kalyoncu University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Estimated)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Surgical Incision Drape
Participants in this group will have their endotracheal tube (ETT) secured using a surgical incision drape. This method will be evaluated for its efficacy in preventing unplanned extubation and wound complications compared to the use of silk plasters.
Other: surgical incision drep
To compare the efficacy of surgical incision with silk plaster in ETT fixation.
Other Names:
  • silk plasters
Active Comparator: silk plasters
The endotracheal tube (ETT) of the participants in this group will be secured using silk plasters. This method will be evaluated for its efficacy in preventing unplanned extubation and wound complications compared to the use of a surgical incision drape.
Other: surgical incision drep
To compare the efficacy of surgical incision with silk plaster in ETT fixation.
Other Names:
  • silk plasters

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
demographic data
Time Frame: through study completion, an average of 1 year
It 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.
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
skin ph meter and skin moisture meter
Time Frame: through study completion, an average of 1 year
During 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.
through study completion, an average of 1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Newborn Skin Condition Assessment Scale
Time Frame: through study completion, an average of 1 year
Data 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.
through study completion, an average of 1 year
unplanned extubation
Time Frame: through study completion, an average of 1 year
Data 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.
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hasan Kalyoncu University

Investigators

  • Principal Investigator: Barış Çelik, Hasan Kalyoncu University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2024

Primary Completion (Estimated)

May 15, 2025

Study Completion (Estimated)

July 15, 2025

Study Registration Dates

First Submitted

December 7, 2024

First Submitted That Met QC Criteria

February 12, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 11, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024/101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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