The Effect of Hydrocolloid to Prevent Nasal Injuries in Preterm Infants

Pressure Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06325215
• Other study ID #: SCaglar
• Status: Completed
• Phase: N/A
• Start date: May 5, 2022
• Est. completion date: November 5, 2022

Study information

• Verified date: March 2024
• Source: Istanbul University - Cerrahpasa (IUC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: November 5, 2022
• Est. primary completion date: October 29, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 24 Weeks to 37 Weeks

Eligibility

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.

Related Conditions & MeSH terms

• Crush Injuries
• Pressure Injury
• Pressure Ulcer
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
Turkey	Abide-i Hurriyet Cad. Istanbul University-Cerrahpasa, Florence Nightingale Faculty of Nursing	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University - Cerrahpasa (IUC)

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Pressure Injury 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	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