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.
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
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
Parallel
Dermabond Mini, 0.36ml, Ethicon Johnson and Johnson, Somerville, New Jersey, USA
DeviceDermabond Mini, 0.36ml, Ethicon Johnson and Johnson, Somerville, New Jersey, USA
Steri-StripsTM (3M, St. Paul, Minnesota, USA
DeviceSteri-StripsTM (3M, St. Paul, Minnesota, USA
Monosyn, B.Braun, 118 Pfieffewiesen, Melsungen, Germany
DeviceMonosyn, B.Braun, 118 Pfieffewiesen, Melsungen, Germany
Skin closure time
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
Parents' satisfaction
Parents' satisfaction will be measured in three aspects - ease of wound care, parents' feeling regarding wound management and satisfaction on wound cosmesis. These will be measured using Likert's scale at day 7 and 1 month post operation
Post operative mental health (Post operative pain)
Patient's post operative mental health (Post operative pain) - will be assessed daily from day 1 to day 7. Visual Analog Scale will be used for patients more than 7 years old, whereas FLACC Scale will be used for patients less than 7 years old.
Post operative mental health (Patient's fear towards wound management post operation)
Patient's post operative mental health (Patient's fear towards wound management post operation) - will be measured using Children's Fear Scale at day 0 and day 7 post operation
Wound cosmesis
Cosmetic appearance of skin will be assessed by using the Vancouver Scar Scale on the day 7 and 1 month
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