The Effect of Hydrocolloid to Prevent Nasal Injuries in Preterm Infants

NCT06325215 | Completed

• 1 other identifier: SCaglar
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the effect of using hydrocolloid tapes in preventing pressure injuries on the nose and columella regions caused by non-invasive mechanical ventilation (NIMV) in preterm infants.

Conditions

Pressure Injury

Keywords

nasal injuries; hidrocolloid tape; collumela; non-invasive mechanic ventilation; preterm infants

Outcome Measures

Primary Outcomes (2)

• Neonatal Skin Condition Score

  he measuring tool consists of three items, each with an assessment criterion. These are dryness, erythema, and skin integrity impairment/peeling, respectively. The first item; Dryness (1=Normal, no signs of dryness, 2= Dry skin, visible flaking, 3= Very dry skin, cracking/fissures), the second item; Redness (1= No signs of redness, 2= Visible redness in less than 50% of the body surface, 3= Visible redness in more than 50% of the body surface), the third item; Skin Integrity Impairment / Peeling (1= No signs, 2= Limited impairment/peeling in a small area, 3= Extensive impairment/peeling). Developed in a triple Likert scale format, each item of the scale receives scores from 1 (one) to 3 (three). The lowest score that can be obtained from the scale is 3, and the highest score is 9; with a high total score indicating poor skin condition in the newborn.

  every 12-hour shift over 4 days for assessment

• Pressure İnjury Staging Scale

  The scale consists of six stages: I. Stage: Non-blanchable erythema that does not fade with pressure on intact skin, II. Stage: Partial thickness loss of dermis and blistering, III. Stage: Loss involving full thickness of skin and subcutaneous tissue, IV. Stage: Full thickness tissue loss (bone/muscle visible), Unstageable / Unclassifiable Stage: Loss of all layers of skin or tissues (depth unknown), Suspected Deep Tissue Injury: Depth Unknown.

  every 12-hour shift over 4 days for assessment

Secondary Outcomes (1)

• Neonatal Skin Risk Assessment Scale

  every 12-hour shift over 4 days for assessment

Study Arms (2)

Hydrocolloid tape group

EXPERIMENTAL

In this group, after the columella and nasal area of preterm infants were cleaned and dried with sterile water, hydrocolloid dressings were applied to the areas in contact with the nasal cannula. NasalNem nasal ointment was applied twice a day to the nasal passages in contact with the cannula. If the hydrocolloid dressings melted or peeled off, they were removed, the area was cleaned, and then reapplied. In the data collection process, assessments of the included preterm infants were conducted by two nurses. The upper lip, nasal passages, nasal septum, and columella region of the preterm infants were evaluated.

Other: Hidrocolloid Bant

Control group

NO INTERVENTION

In this group, premature infants underwent the routine procedure of the NICU. As per the clinic's routine procedure, after cleaning and drying the columella and nasal area with sterile water, NasalNem nasal ointment was applied twice a day to the nasal passages in contact with the cannula. In the data collection process, assessments of the included preterm infants were conducted by two nurses. The upper lip, nasal passages, nasal septum, and columella region of the preterm infants were evaluated.

Interventions

Hidrocolloid Bant OTHER

In this group, after the columella and nasal area of preterm infants were cleaned and dried with sterile water, hydrocolloid dressings were applied to the areas in contact with the nasal cannula. NasalNem nasal ointment was applied twice a day to the nasal passages in contact with the cannula. If the hydrocolloid dressings melted or peeled off, they were removed, the area was cleaned, and then reapplied.

Hydrocolloid tape group

Eligibility Criteria

• Age: 24 Weeks - 37 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Were born at less than 37 weeks of gestation,
• Were admitted to the neonatal intensive care unit,
• Received non-invasive mechanical ventilation support for at least 4 days,

You may not qualify if:

• Have been intubated,
• Have congenital anomalies,
• Have a history of nasal trauma,
• Have skin diseases,
• Have sensitivity or allergies to hydrocolloid tape.

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Abide-i Hurriyet Cad. Istanbul University-Cerrahpaşa, Florence Nightingale Faculty of Nursing

Istanbul, 34381, Turkey (Türkiye)

Location

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: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Masking Details: After providing information about the study to the parents of preterm newborns who met the inclusion criteria, informed consent forms were obtained without disclosing which group their babies would be assigned to. The research outcome measurements were recorded by two nurses working at NICU. Prior to the study, necessary training and information about the form and process were provided to the nurses. The data analysis was conducted by an independent statistician.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized Controlled Experimantal

Study Record Dates

• First Submitted: March 11, 2024
• First Posted: March 22, 2024
• Study Start: May 5, 2022
• Primary Completion: October 29, 2022
• Study Completion: November 5, 2022
• Last Updated: March 22, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)