The Impact of Hydrocolloid on Preventing Pressure Injuries in the Nose and Columella of Preterm Infants: " A Randomized Controlled Trial"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Pressure İnjury Staging Scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Care Provider, Investigator)
盲法说明
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.
入排标准
- 年龄范围
- 24 Weeks 至 37 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Have been intubated,
- •Have congenital anomalies,
- •Have a history of nasal trauma,
- •Have skin diseases,
- •Have sensitivity or allergies to hydrocolloid tape.
研究组 & 干预措施
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.
干预措施: Hidrocolloid Bant (Other)
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.
结局指标
主要结局
Pressure İnjury Staging Scale
时间窗: every 12-hour shift over 4 days for assessment
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.
Neonatal Skin Condition Score
时间窗: every 12-hour shift over 4 days for assessment
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.
次要结局
- Neonatal Skin Risk Assessment Scale(every 12-hour shift over 4 days for assessment)
研究者
Seda Caglar
Principal Investigator
Istanbul University - Cerrahpasa