About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Dermabond Mini, 0.36ml, Ethicon Johnson and Johnson, Somerville, New Jersey, USA
- Steri-StripsTM (3M, St. Paul, Minnesota, USA
- Monosyn, B.Braun, 118 Pfieffewiesen, Melsungen, Germany
Treatment groups
Locations
1Map coordinates are unavailable for these locations. Locations are shown below instead.