A Randomised Controlled Trial To Evaluate The Skin Closure Time, Parents' Satisfaction, Post Operative Mental Health, Wound Cosmesis and Wound Complication Of Skin Closure Using Adhesive Glue, Adhesive Tape And Suture In Paediatric Surgery Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Skin closure time
研究概览
简要总结
This study is a randomised controlled trial to evaluate the skin closure time, parents' satisfaction, post operative mental health, wound cosmesis and wound complication of skin closure using adhesive glue, adhesive tape and suture in paediatric surgery patients.
Primary objective is to compare skin closure time required by using adhesive glue, adhesive tape and suture. Secondary objectives are to compare parents' satisfaction, post operative mental health, wound cosmesis and wound complication of skin closure using adhesive glue, adhesive tape and suture in paediatric surgery patients.
This study will be conducted from 26th August 2024 to 31st May 2025. It will take place at Hospital Pakar Kanak-Kanak UKM (HPKK), involving paediatric surgery patients undergoing clean or clean contaminated surgeries.
The sample size calculated is 30 per group, a total of 90 patients for three groups. The sampling method used is simple random sampling method.
In group A, skin will be closed using adhesive glue (Dermabond Mini, 0.36ml, Ethicon Johnson and Johnson, Somerville, New Jersey, USA). Skin closure in group B will be done using adhesive tape (Steri-StripsTM (3M, St. Paul, Minnesota, USA). In group C, skin will be closed using suture (Monosyn, B.Braun, 118 Pfieffewiesen, Melsungen, Germany) 4/0.
详细描述
This study is a randomised controlled trial to evaluate the skin closure time, parents' satisfaction, post operative mental health, wound cosmesis and wound complication of skin closure using adhesive glue, adhesive tape and suture in paediatric surgery patients.
Primary objective is to compare skin closure time required by using adhesive glue, adhesive tape and suture. Secondary objectives are to compare parents' satisfaction, post operative mental health, wound cosmesis and wound complication of skin closure using adhesive glue, adhesive tape and suture in paediatric surgery patients.
This study will be conducted from 26th August 2024 to 31st May 2025. It will take place at Hospital Pakar Kanak-Kanak UKM (HPKK), involving paediatric surgery patients undergoing clean or clean contaminated surgeries. Inclusion criteria includes patients aged 18 years or less, clean and clean contaminated surgery, wound length of 1-10cm, surgical wound amenable to closure with the three skin closure techniques. Exclusion criteria includes scrotal or penile incision, contaminated or dirty wound, repeated surgical procedures at the surgical site, wound that is not amenable to primary closure with the three techniques, patient with known allergy to cyanoacrylate, patients receiving chemotherapy, immunosuppression, systemic corticosteroids, or with known malignancy.
The sample size calculated is 30 per group, a total of 90 patients for three groups. The sampling method used is simple random sampling method.
In group A, skin will be closed using adhesive glue (Dermabond Mini, 0.36ml, Ethicon Johnson and Johnson, Somerville, New Jersey, USA). Skin closure in group B will be done using adhesive tape (Steri-StripsTM (3M, St. Paul, Minnesota, USA). In group C, skin will be closed using suture (Monosyn, B.Braun, 118 Pfieffewiesen, Melsungen, Germany) 4/0.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (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 aged 18 years or less
- •clean and clean contaminated surgery
- •wound length of 1-10cm
- •surgical wound amenable to closure with the three skin closure techniques
排除标准
- •scrotal or penile incision
- •contaminated or dirty wound
- •repeated surgical procedures at the surgical site
- •wound that is not amenable to primary closure with the three techniques
- •patient with known allergy to cyanoacrylate
- •patients receiving chemotherapy, immunosuppression, systemic corticosteroids, or with known malignancy
研究组 & 干预措施
Group A - Adhesive glue
Dermabond Mini, 0.36ml, Ethicon Johnson and Johnson, Somerville, New Jersey, USA
干预措施: Dermabond Mini, 0.36ml, Ethicon Johnson and Johnson, Somerville, New Jersey, USA (Device)
Group B - Adhesive tape
Steri-StripsTM (3M, St. Paul, Minnesota, USA
干预措施: Steri-StripsTM (3M, St. Paul, Minnesota, USA (Device)
Group C - Suture
Monosyn, B.Braun, 118 Pfieffewiesen, Melsungen, Germany
干预措施: Monosyn, B.Braun, 118 Pfieffewiesen, Melsungen, Germany (Device)
结局指标
主要结局
Skin closure time
时间窗: Day 0
Skin closure time will be measured using stopwatch and documented in unit minutes and seconds. It will include the time taken for dressing application, but will not include the time taken for subcutaneous layer closure
次要结局
- Parents' satisfaction(Day 7 and 1 month post operation)
- Post operative mental health (Post operative pain)(Day 1 to day 7)
- Post operative mental health (Patient's fear towards wound management post operation)(Day 0 and day 7)
- Wound cosmesis(Day 7 and 1 month post operation)
- Wound complication(Day 7 and 1 month post operation)