Clinical trial NCT06325215: The Effect of Hydrocolloid to Prevent Nasal Injuries in Preterm Infants
Official title: The Impact of Hydrocolloid on Preventing Pressure Injuries in the Nose and Columella of Preterm Infants: " A Randomized Controlled Trial"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pressure Injury
Keywords: nasal injuries
hidrocolloid tape
collumela
non-invasive mechanic ventilation
preterm infants
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2024-03-22
Enrollment: 56
Sex: ALL
Minimum age (years): 24
Maximum age (years): 37
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Experimantal
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Neonatal Skin Condition Score
timeFrame: every 12-hour shift over 4 days for assessment
measure: Pressure İnjury Staging Scale
timeFrame: every 12-hour shift over 4 days for assessment
Secondary outcomes:
measure: Neonatal Skin Risk Assessment Scale
timeFrame: every 12-hour shift over 4 days for assessment
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Abide-i Hurriyet Cad. Istanbul University-Cerrahpaşa, Florence Nightingale Faculty of Nursing
Study officials:
References: