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

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

76

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 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

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
Intervention / Treatment
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

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

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

Ege University

Investigators

  • 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)

October 19, 2022

Primary Completion (Actual)

November 27, 2023

Study Completion (Actual)

December 27, 2023

Study Registration Dates

First Submitted

March 16, 2025

First Submitted That Met QC Criteria

April 6, 2025

First Posted (Actual)

April 13, 2025

Study Record Updates

Last Update Posted (Actual)

April 13, 2025

Last Update Submitted That Met QC Criteria

April 6, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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