Comparison of Foam Dressing Versus Silver-Impregnated Foam Dressing for Prevention of Peristomal Complications in Pediatric Tracheostomy: A Prospective Randomized Controlled Trial Using Validated Assessment Tools
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Incidence of Peristomal Complications
研究概览
简要总结
This study compares two types of wound dressings used after tracheostomy surgery in children: standard foam dressing and silver-impregnated foam dressing.
Tracheostomy is a surgical procedure that creates an opening in the neck to help children breathe. Skin problems around the tracheostomy site are common, occurring in up to 29% of pediatric patients.
The purpose of this study is to determine if silver-impregnated foam dressing is better than standard foam dressing in preventing skin complications around the tracheostomy site.
Fifty children (ages 0-18 years) undergoing tracheostomy surgery were randomly assigned to receive either standard foam dressing or silver-impregnated foam dressing. All patients received the same standardized wound care. Patients were followed for one month after surgery.
The main outcome measured was the rate of skin complications. Secondary outcomes included pressure ulcer risk assessment using the Braden Q Scale and wound staging using the National Pressure Injury Advisory Panel classification.
详细描述
Peristomal skin complications represent a significant concern following pediatric tracheostomy, with reported incidence rates up to 29%. These complications include pressure ulcers, infections, granulation tissue, and skin breakdown.
This prospective randomized controlled trial was conducted at a single tertiary care center. Fifty pediatric patients undergoing elective tracheostomy were enrolled and randomly assigned to one of two groups:
Group A (n=25): Standard foam dressing Group B (n=25): Silver-impregnated foam dressing
All patients received a standardized postoperative care protocol including:
- Velcro ties with foam padding for tube securement
- Daily wound assessment
- Neutral head positioning for ventilated patients
- Standardized dressing change criteria
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 0 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients aged 0-18 years
- •Undergoing elective tracheostomy
- •Tracheostomy performed by the pediatric otolaryngology team
- •Followed in neonatal or pediatric intensive care units
排除标准
- •Patients over 18 years of age
- •Emergency tracheostomy
- •Percutaneous tracheostomy
- •Pre-existing skin diseases
- •History of head and neck surgery
- •Tracheostomy performed during airway reconstruction surgery
研究组 & 干预措施
Standard Foam Dressing
Patients received standard foam dressing for tracheostomy wound care (Group A, n=25)
干预措施: Standard Foam Dressing (Device)
Silver-Impregnated Foam Dressing
Patients received silver-impregnated foam dressing for tracheostomy wound care (Group B, n=25)
干预措施: Silver-Impregnated Foam Dressing (Device)
结局指标
主要结局
Incidence of Peristomal Complications
时间窗: 30 days postoperatively
Measure DescriptionOverall rate of peristomal complications including infection, pressure ulcer, granulation tissue, and skin necrosis. Measured as percentage of patients developing any complication.
次要结局
- Braden Q Risk Assessment Scale Score(Postoperative days 1, 7, 14, and 21)
- Pressure Ulcer Severity by NPIAP Classification(30 days postoperatively)
研究者
SERAP SAHIN ONDER
associate professor
Acibadem Atasehir Hospital