Comparıson Of Sılıcone And Acrylıc Medıcal Adhesıve Tapes On Skın İnjury Nasogastrıc Tube

April 6, 2025 updated by: Ebru Ozel, Ege University

Comparıson Of The Effect Of Sılıcone And Acrylıc Medıcal Adhesıve Tapes On Skın İnjury In Fıxatıon Of The Nasogastrıc Tube

This randomized controlled experimental study was conducted to compare the effects of silicone and acrylic medical adhesive tapes on medical-adhesive related skin injury in the fixation of nasogastric tubes in patients being monitored in intensive care.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This randomized controlled experimental study was conducted to compare the effects of silicone and acrylic medical adhesive tapes on medical-adhesive related skin injury in the fixation of nasogastric tubes in patients being monitored in intensive care.

The population of the research consisted of patients with nasogastric tubes who were hospitalized in the Neurology Intensive Care Unit of Ege University Hospital (Health Practice and Research Center) between the dates of 01.06.2022 and 31.12.2023. The sample of the study consisted of 76 patients who were hospitalized in the Neurology Intensive Care Unit during this date range, had a nasogastric tube inserted, complied with the limitations of the study and agreed to participate in the study. Patients were stratified according to their age groups and assigned to experimental and control groups by block randomisation technique.

The nasogastric tube of the patients in the control group was fixed with acrylic medical adhesive tape which is used in routine practice, and the nasogastric tube of the patients in the experimental group was fixed with silicone medical adhesive tape. Starting from these condday following the nasogastric tube insertion, the medical adhesive tape that enables the fixation of the nasogastric tube was removed by wetting it with a sterile tampon impregnated with distilled water, and the patient's nasal skin was observed for 10 minutes each time, during 7 days for the presence of erythema, edema, denudation, dryness, infection, and vesicles. Then, the same medical adhesive tape was applied again and the tube was fixed. The data were analyzed in SPSS 25.0 program. Mann-Whitney U test, Pearson Chi-square test and Fisher's Exact probability test were used to analyze the data. The nasogastric tube of the patients in the control group was fixed with acrylic medical adhesive tape which is used in routine practice, and the nasogastric tube of the patients in the experimental group was fixed with silicone medical adhesive tape.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
76

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Locations

  • Turkey
    • Bornova
      • İzmir, Bornova, Turkey
        • Ege University Hospital (Health Practice and Research Center)

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Feeding with a nasogastric tube
  • Being between the ages of 18-85
  • Voluntarily participating in the study
  • Having the first nasogastric tube inserted after admission to the Intensive Care Unit and having the tube detected by the researcher.

Exclusion Criteria:

  • Having any dermatological disease
  • Having a history of allergy
  • Having a lesion on the skin of the nose
  • Failure to detect the tube by the researcher when the first nasogastric tube was inserted after admission to the Intensive Care Unit.

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: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Control group
Medical adhesive tape with hypoallergenic acrylic adhesive used in standard practice was used in the control group (n=38).
Other: medical adhesive tape
After the patients were assigned to the control and experimental groups, the tube of the patient in the control group was fixed with acrylic medical adhesive tape, and the tube of the patient in the experimental group was fixed with silicone medical adhesive tape.
Experimental: Experimental group
Silicone medical adhesive tape was used in the experimental group (n=38).
Other: medical adhesive tape
After the patients were assigned to the control and experimental groups, the tube of the patient in the control group was fixed with acrylic medical adhesive tape, and the tube of the patient in the experimental group was fixed with silicone medical adhesive tape.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Skin Evaluation Form
Time Frame: seven days
Skin Assessment Form is a form developed by a dermatologist and researcher to evaluate whether there is skin injury on the nose skin of patients. The nose skin of patients was evaluated daily in terms of erythema, edema, denudation, dryness, infection, and vesicle presence and recorded on this form.
seven days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pain Assessment Form
Time Frame: seven days
The Pain Assessment Form is a form used to determine the presence and severity of pain during the removal of medical adhesive tape from the patient's nose skin. The 3 different pain scales (numeric, facial and behavioral) routinely used in the intensive care unit where the study was conducted and the patient's pain score are included in this form
seven days

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ege University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Ebru Özel, Ph.D, Ege 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 19, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 27, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 27, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 16, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 13, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 13, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EGE-HMF-EO-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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