The Effect of Three Different Nasogastric Tube Fixation Materials on Pressure Injury

NCT06819800 | Completed

• 1 other identifier: ayse_kaya_61
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 2

Brief Summary

This randomized controlled experimental study aims to comparatively determine the effects of three different nasogastric tube fixation materials (elastic plaster, medical silk plaster, transparent waterproof plaster) on pressure injuries in adult patients hospitalized in ICU. This study was carried out in the Intensive Care Units (ICU) of a university-affiliated training and research hospital in Istanbul, Turkey. 84 patients were divided into three groups of 28 patients each, and were fixed with different materials. Data were collected using the Patient Information Form, Patient Follow-up Form, Braden Pressure Wound Risk Assessment Scale, Glasgow Coma Scale, and Nasogastric Tube-Related Pressure Injuries Staging and Follow-up Form. The data were analyzed using the Statistical Package for Social Sciences (SPSS) v27 statistical analysis program. The frequency and severity of pressure injuries between groups were evaluated by statistical methods such as Chi-square analysis, analysis of variance and Bonferroni test.

Conditions

Pressure Ulcer; Nursing Care

Keywords

Intensive Care Unit; nasogastric tube fixation; pressure injury; medical equipment; nursing

Outcome Measures

Primary Outcomes (2)

• Glasgow Coma Scale

  Developed in Glasgow, Scotland in 1974, the GCS is a common scale used to assess the state of consciousness of comatose patients. It consists of three parameters: "eye openness", "verbal and motor response". The total score ranges from 3 to 15, with 3 points indicating deep coma and 15 points indicating full awareness and alertness.

  Baseline, 72 hours and average 15 days

• Braden Pressure Ulcer Risk Assessment Scale

  Developed in 1984 by Braden and used to assess pressure sore risk factors, this scale was improved by Braden and Bergstrom in 1987. The subscales of the scale include stimulus perception, activity, movement, moisture, nutrition and friction-tearing. The scores obtained from the sub-dimensions constitute the total scale score. The score range is 6-23, and the lower the score, the higher the risk of developing pressure sores. According to the scale score, risk levels are classified as "12 and below high risk", "13-14 medium risk", "15-16 low risk". A score of 15-18 is considered low risk in people aged 75 years and older.

  Baseline, 72 hours and average 15 days

Secondary Outcomes (3)

• Nasogastric Tube Related Pressure Injuries Follow-up Questionnaire

  on average 10-15 days after the wound is formed in the patient

• patient information questionnaire

  Baseline

• patient nasal area monitoring questionnaire

  Baseline, 72 hours and average 15 days

Study Arms (3)

Elastic Flaster

ACTIVE COMPARATOR

Elastic Flaster: Elastic flaster is a hypoallergenic therapeutic product and is made of an elastic, non-woven fabric. It has a polyacrylate adhesive, which allows it to be easily fixed. Thanks to its porous structure, it allows air intake, recognition and moisture permeability. Elastic plasters, which easily adapt to the connections with their flexible structure body structures, adapt to the natural movements of the skin and increase the comfort of the patient. This feature may be especially preferred for patients who move a lot. Although elastic dressings are generally more affordable than other types of dressings, they may increase costs in the long term due to frequent replacement. In the Intensive Care Unit, elastic plasters are routinely used for nasogastric tube fixation.

Other: Elastic Flaster

Medical Silk Flaster

EXPERIMENTAL

Medical Silk Flasters: Medical silk flaster is a medical material made of acetate silk with rubber-based fittings containing mineral oxide. It is used for fixation in surgical applications. It is effective in fixing materials such as catheters, cover cloths and wound dressings thanks to its strong adhesive properties. The material used in its content provides a clean appearance compatible with the skin and increases comfort. However, this type of flasters may cause skin irritation in some patients with prolonged use. The cost of silk flasters is moderate, and their high adhesive properties make them cost-effective in the long term as they require fewer changes.

Other: Medical Silk Flaster

Transparent Waterproof Flaster

EXPERIMENTAL

Transparent Waterproof Waterproof Flaster The transparent waterproof patch is a hypoallergenic product suitable for sensitive skin. It offers an ideal use for the storage of maintenance and repair areas. It is effectively used for fixing the number of medical supplies. The transparent structure allows for clearer observation of operations. These flasters perform well even in humid environments and reduce the risk of infection. It has a strong adhesive, long-lasting feature and does not cause any residue on the skin after use. It can be easily torn by hand both transversely and longitudinally, ensuring user practicality.

Other: Transparent Waterproof Flaster

Interventions

Transparent Waterproof Flaster OTHER

Patients determined by randomization method were divided into three groups. "Patient Information Form", 'Patient Follow-up Form', 'Glasgow Coma Scale' and 'Braden Pressure Ulcer Risk Assessment Scale' were applied to the patients in the transparent waterproof flaster group, one of the experimental groups. Nasogastric tube care was applied at 24-hour intervals. The dorsum of the nose was first cleaned with saline and then disinfected with a skin antiseptic containing alcohol and chlorhexidine gluconate. Afterwards, a transparent waterproof flaster was applied. The transparent waterproof flaster was prepared using the "nasal preparation by pants tape method" technique. Afterwards, the "Patient Follow-up Form", "Glasgow Coma Scale" and "Braden Pressure Injury Risk Diagnostic Scale" were re-administered by the investigator at 72 hours and at discharge. If pressure injury developed, the "Nasogastric Tube-Related Pressure Injury Staging Form" was completed.

Transparent Waterproof Flaster

Medical Silk Flaster OTHER

Patients determined by randomization method were divided into three groups. "Patient Information Form", 'Patient Follow-up Form', 'Glasgow Coma Scale' and 'Braden Pressure Wound Risk Assessment Scale' were applied to the patients in the medical silk flaster group, one of the experimental groups. Nasogastric tube care was applied at 24-hour intervals. The dorsum of the nose was first cleaned with saline and then disinfected with a skin antiseptic containing alcohol and chlorhexidine gluconate. Afterwards, a medical silk flaster was applied. The medical silk flaster was prepared using the "nasal preparation by pants tape method" technique. Afterwards, the "Patient Follow-up Form", "Glasgow Coma Scale" and "Braden Pressure Injury Risk Diagnostic Scale" were re-administered by the investigator at 72 hours and at discharge. If pressure injury developed, the "Nasogastric Tube-Related Pressure Injury Staging Form" was completed.

Medical Silk Flaster

Elastic Flaster OTHER

Patients determined by randomization method were divided into three groups. "Patient Information Form", 'Patient Follow-up Form', 'Glasgow Coma Scale' and 'Braden Pressure Wound Risk Assessment Scale' were administered to the patients in the control group, which was in the elastic flaster group. Nasogastric tube care was applied at 24-hour intervals. The dorsum of the nose was first cleaned with saline and then disinfected with a skin antiseptic containing alcohol and chlorhexidine gluconate. Afterwards, an elastic flaster was applied. The elastic flaster was prepared using the "preparation of the nose by the pants tape method" technique. Afterwards, the "Patient Follow-up Form", "Glasgow Coma Scale" and "Braden Pressure Injury Risk Diagnostic Scale" were re-administered by the investigator at 72 hours and at discharge. If pressure injury developed, the "Nasogastric Tube-Related Pressure Injury Staging Form" was completed.

Elastic Flaster

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Between the ages of 18-65
• Duration of hospitalization in the ICU should be at least 24 hours
• Having no cognitive and affective problems
• Nasogastric (NG) tube insertion for the first time and tube placement for at least 72 hours
• Nasogastric tube maintenance at least once a day
• Glasgow Coma Scale (GCS) score of 9 and above
• Oxygen support is not provided with medical devices
• No skin problem that may prevent skin diagnostics
• No burns/trauma in the face and nose area/operation not to spend
• No history of pressure injury to the nose
• The absence of a diagnosis of Diabetes Mellitus (DM) was determined.

You may not qualify if:

• Under 18 or over 65 years of age
• Having a state of consciousness or affective problem(s)
• GCS score below 9
• The presence of facial problem(s) that may prevent nasogastric tube insertion.

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (2)

Bezmialem Vakıf University

Istanbul, Eyüp Sultan, 34050, Turkey (Türkiye)

Location

Bezmialem Vakif University

Istanbul, Eyüpsultan, 34050, Turkey (Türkiye)

Location

Related Publications (21)

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  BACKGROUND

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• [1] EUAP-PPPIA (European Pressure Ulcer Advisory Panel- National Pressure Ulcer Advisory PanelPan Pacific Pressure Injury Alliance) 2014. Prevention and Treatment of Pressure ulcers: Quick reference guide. ISBN-13: 978-0-9579343-6-https://www.epuap.org/wp content/uploads/2010/10/NPUAP-EPUAPPPPIA-Quick-Reference-Guide-2014-DIGITAL.pdf.

  RESULT

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study was conducted with 3 groups. The experimental groups consisted of medical silk plaster and transparent waterproof plaster groups. The control group consisted of the elastic bandage group, which was routinely applied in intensive care unit. Patients were randomly assigned to the groups and 3 different fixation materials were applied according to their group. Fixation materials were changed every 24 hours and skin care was performed. Patients were followed up until discharge.

Study Record Dates

• First Submitted: January 8, 2025
• First Posted: February 11, 2025
• Study Start: December 28, 2023
• Primary Completion: January 15, 2024
• Study Completion: June 28, 2024
• Last Updated: February 11, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)