Medical-adhesive; Skin InjuryNCT06925347
Comparıson Of Sılıcone And Acrylıc Medıcal Adhesıve Tapes On Skın İnjury Nasogastrıc Tube
A study testing medical adhesive tape in people with Medical-adhesive; Skin Injury, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Medical-adhesive; Skin Injury
- What is being tested?
- medical adhesive tape
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Oct 2022to 27 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ege University Hospital (Health Practice and Research Center)
Izmir, Bornova
About this study
Official title: 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.
Read the 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.
- Conditions
- Medical-adhesive; Skin Injury
- Being tested
- medical adhesive tape
- Keywords
- nasogastric tube, medical-adhesive, silicone, acrylic, skin injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
medical adhesive tapeOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Medical adhesive tape with hypoallergenic acrylic adhesive used in standard practice was used in the control group (n=38). Receives: Other: medical adhesive tape |
| Experimental group | Experimental | Silicone medical adhesive tape was used in the experimental group (n=38). Receives: Other: medical adhesive tape |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin Evaluation Form
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.
Measured: seven days
Secondary outcomes (1)
Pain Assessment Form
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
Measured: seven days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2025
- Study start19 Oct 2022
- Primary completion27 Nov 2023
- Study completion27 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medical-adhesive; Skin InjuryStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- It consists of 2 groups: control and experimental group.
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebru Ozel, Ege University
- Investigators
- Ebru Özel, Ph.D, Study director, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06925347
- Sponsor's protocol ID
- EGE-HMF-EO-01
- Status last verified
- Mar 2025
- First submitted
- 16 Mar 2025
- Last updated
- 13 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparıson Of The Effect Of Sılıcone And Acrylıc Medıcal Adhesıve Tapes On Skın İnjury In Fıxatıon Of The Nasogastrıc Tube
- ClinicalTrials.gov ID
- NCT06925347
- Acronym / sponsor ID
- EGE-HMF-EO-01
- Conditions
- Medical-adhesive; Skin Injury
- Keywords
- nasogastric tube, medical-adhesive, silicone, acrylic, skin injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 19 Oct 2022 (actual)
- Primary completion
- 27 Nov 2023 (actual)
- Study completion
- 27 Dec 2023 (actual)
- First posted
- 13 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- It consists of 2 groups: control and experimental group.
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: medical adhesive tapeMedical adhesive tape with hypoallergenic acrylic adhesive used in standard practice was used in the control group (n=38). |
| Experimental group | Experimental | Other: medical adhesive tapeSilicone medical adhesive tape was used in the experimental group (n=38). |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| medical adhesive tapeAfter 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. | Other | Control group, Experimental group |
Primary outcome
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.
1 secondary outcome
Pain Assessment Form
Time frame: seven days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2025.
Related trials for Medical-adhesive; Skin Injury
Recruiting
Evaluation of a Switchable Acrylic Adhesive Drape for Safer Removal in Negative Pressure Wound Therapy Applications.
Frequency and Type of Medical Adhesive-Related Skin Injury, NPWT Drape Seal Effectiveness Rate (or Leak Incidence Rate)
Not yet recruiting
Surgical Dressing Study Comparing SYLKE vs Other Common Incisional Dressings Following Abdominoplasty/Panniculectomy Patients
Hypertrophic Surgical Scar, Medical Adhesive Related Skin Injury
Not yet recruiting
Cohesive Bandage Fixation of Pulse Oximeter Probes and Skin Condition in Preterm Neonates
Skin Injury, Premature Birth
Recruiting
Medical Adhesive and Barrier Products for Preventing MARSI in Central Venous Catheter Dressings
Medical Adhesive Related Skin Injury, Central Venous Catheter
Enrolling by invitation
Frequency of Care for Peripherally Inserted Central Vascular Access In the Prevention of Marsi
Colon Cancer, Cancer Pancreas
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ebru Özel, Ph.D study director
Ege University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing medical adhesive tape in people with Medical-adhesive; Skin Injury, run by Ege University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin Evaluation Form (time frame: seven days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2025.