The Effect of Hydrocolloid to Prevent Nasal Injuries in Preterm Infants

The Impact of Hydrocolloid on Preventing Pressure Injuries in the Nose and Columella of Preterm Infants: " A Randomized Controlled Trial"

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.

Study Overview

• Status: Completed
• Conditions: Pressure Injury
• Intervention / Treatment: Other: Hidrocolloid Bant

Detailed Description

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.

This study is a, prospective randomized controlled trial.The research population comprised 56 premature neonates born at 37 weeks of gestation or less, who received NIMV support in the neonatal intensive care unit (NICU) between May 2022 and November 2022. Participants were randomly assigned to one of two groups; the first group (n=28) received hydrocolloid band application, while the second group (n=28) served as the control group. "Data Collection Form", "Neonatal Skin Risk Assessment Scale (NSRAS)", "Neonatal Skin Condition Score (NSCS)" and "Pressure Injury Staging Scale (PISS)" were used for data collection.

Intervention Tools:

For the NIMV of premature infants, Alpha brand nasal cannulas were used. The nasal cannula has soft binasal tips and is suitable for both low and high flow oxygen usage. A new sterile cannula was used for each infant.

Abfen-Farma brand Nasalnem Nasal Ointment was used for premature infants. Nasalnem Nasal Ointment aids in healing wounds inside the nose, resolving problems such as mucosa regeneration and mucosal wounds, supporting the mucosa, and alleviating issues like crusting and dryness.

In the hydrocolloid barrier group, Hartmann brand hydrocolloid tape was used.Hydrocolloid tape is a type of dressing used in wound care, consisting of a flexible, water-resistant adhesive containing a gel-forming substance such as pectin, gelatin or cellulose. Hydrocolloid tapes create a moist environment by being applied directly onto the wound, which accelerates healing and helps prevent infection. The adhesive layer of the dressing forms a barrier that protects the wound from external contaminants while providing support and reducing friction. Hydrocolloid tapes are available in various shapes and sizes and have the ability to remain in place for several days without needing to be changed. This feature can be beneficial in terms of patients, caregivers and cost-effectiveness .

Hydrocolloid band group (n=28): In this group, after the columella and nose areas of preterm infants were cleaned and dried with sterile water, hydrocolloid bands were placed on the areas where the nasal cannula made contact. NasalNem nasal ointment was applied twice a day to the nasal passages in contact with the cannula. If the hydrocolloid bands melted or detached, they were removed, the area was cleaned, and then reapplied. The nose and columella regions of preterm infants were evaluated every 12 hours for a total of 4 days/96 hours using the NSRAS scale for skin risk status, the NSCS scale for dryness, redness and peeling status, and the PISS scale for the occurrence of pressure injuries.

Control group (n=28): Preterm infants in this group were subjected to the routine procedure of the NICU. According to the clinic's routine procedure, after cleaning and drying the columella and nose areas with sterile water, NasalNem nasal ointment was applied twice a day to the nasal passages in contact with the cannula. The nose and columella regions of preterm infants were evaluated every 12 hours for a total of 4 days/96 hours using the NSRAS scale for skin risk status, the NSCS scale for dryness, redness and peeling status and the PISS scale for the occurrence of pressure injuries.

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34381
    • Abide-i Hurriyet Cad. Istanbul University-Cerrahpaşa, Florence Nightingale Faculty of Nursing

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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,
• Were approved for inclusion in the study by their families.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hydrocolloid tape group; 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; 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.
No Intervention: Control group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neonatal Skin Risk Assessment Scale	This scale consists of six parameters specific to the newborn population (general physical condition, mental state, mobility, activity, nutrition, and moisture), and it is adjusted according to gestational age. Each parameter is scored from 1 to 4. The total score ranges from 6 to 24. A high score indicates an increased risk of skin integrity impairment in the newborn, whereas a low score indicates a low risk of skin integrity impairment.	every 12-hour shift over 4 days for assessment

Collaborators and Investigators

• Sponsor: Istanbul University - Cerrahpasa (IUC)

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2022
• Primary Completion (Actual): October 29, 2022
• Study Completion (Actual): November 5, 2022

Study Registration Dates

• First Submitted: March 11, 2024
• First Submitted That Met QC Criteria: March 21, 2024
• First Posted (Actual): March 22, 2024

Study Record Updates

• Last Update Posted (Actual): March 22, 2024
• Last Update Submitted That Met QC Criteria: March 21, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: preterm infants; nasal injuries; hidrocolloid tape; collumela; non-invasive mechanic ventilation
• Additional Relevant MeSH Terms: Skin Diseases; Skin Ulcer; Wounds and Injuries; Crush Injuries; Pressure Ulcer
• Other Study ID Numbers: SCaglar

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No