Comparison of Two Different Solutions for Peristomal Skin Care in Patients With Pediatric Stoma: A Randomized Controlled Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Skin temperature measurement around stoma
研究概览
简要总结
The aim of this study is to determine the effect of two different skin care solutions used in stoma care on peristomal skin integrity and compare them with each other.
详细描述
ABSTRACT
The research was planned as a randomized controlled experiment. Simple stratified randomization according to age will be done. The purpose of the study will be explained to the children and their parents who agreed to participate in the study and their consent will be obtained.
Study Groups: In the study, there will be 2 groups with 12 patients in each group.
- Distilled water+Ph 5.5 baby shampoo for stoma care of patients in the first group (routine care of the clinic)
- 0.9% saline solution for stoma care of patients in the second group Randomization: It will be provided as 2 groups, using the Random Sequence Generator on www.random.org. The randomization provided by the program can be accessed from the link https://www.random.org/integers/?num=24\&min=1\&max=24\&col=2\&base=10\&format=html\&rnd=new.
Intervention Procedure: After obtaining written consent, peristomal skin integrity of all participants will be evaluated on day 0 post-op prior to randomization.
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 (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Day 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who volunteered to participate in the study and received Informed Voluntary Consent from their parents.
- •Products used in routine clinical care in skin care (distilled water + baby shampoo), patients for whom the use of 0.9% saline is appropriate
- •Patients who do not have any other underlying disease that may affect peristomal skin integrity
- •Patients included in the study from the 0th day following the colostomy opening
- •Patients who can be observed at least on the 7th day
排除标准
- •Patients who did not volunteer to participate in the study and who could not obtain Informed Voluntary Consent from their parents
- •Patients with a stoma other than a colostomy (ileostomy, etc.)
- •Products used in routine clinical care in skin care (distilled water + baby shampoo), patients for whom the use of 0.9% saline is not suitable
- •Patients with another underlying disease that may affect peristomal skin integrity
- •Patients on the 1st day and after the colostomy opening
- •Patients who cannot be observed for at least 7 days
结局指标
主要结局
Skin temperature measurement around stoma
时间窗: change between the 0th and the 7th day
Skin temperature measurement around stoma will be measured with a portable infrared device.
Pittman Ostomy Complication Severity Index
时间窗: change between the 0th and the 7th day
It is a 9-parameter evaluation scale developed by Joyce Pittman in 2014, and its validity and reliability in Turkish were performed by Arslantaş et al. in 2019. The purpose of the scale is to evaluate the frequency and severity of early postoperative complications during follow-up in individuals with stoma. This index Evaluates leakage, peristomal irritant dermatitis, pain, bleeding in or around the stoma, stomal necrosis, stenosis, retraction, mucocutaneous separation, and hyperplasia All complications 0 to 3 (0 = absent, 1 = mild, 2 = moderate, 3 = severe) (The total score ranges from 0 to 27. Higher scores indicate more severe ostomy complications)
skin moisture around the soma
时间窗: change between the 0th and the 7th day
percent of (%)skin moisture around the soma will be measured with a portable device brand BRD
skin pH measurement around stoma
时间窗: change between the 0th and the 7th day
skin pH measurement around stoma will be measured with a portable device brand BRD
次要结局
未报告次要终点
研究者
ESRA ARDAHAN AKGUL
Assistant Professor, Principal Investigator
Izmir Katip Celebi University