Clinical trial NCT06713772: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Skin Wound
Lead sponsor: National University of Malaysia
Sponsor class: OTHER
First posted: 2024-12-03
Enrollment: 90
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Primary outcome, 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.

Secondary outcomes, 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. Patient's post operative mental health will be measured in two aspects, post operative pain and patient's fear towards wound management post operation. 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. Patient's fear towards wound management post operation will be measured using Children's Fear Scale at day 0 and day 7 post operation. Cosmetic appearance of skin will be assessed by using the Vancouver Scar Scale on the day 7 and 1 month. Wound complication will be assessed using ASEPSIS Score on the day 7 and 1 month post operation.

Data will be analysed using IBM SPSS Statistics Version 29. All continuous data (wound cosmesis, wound complication, post operative pain) will be checked for normality distribution using histogram, bell shape curve, skewness and kurtosis. If it is normally distributed, it will be presented in mean and standard deviation and further analysed and compared among three groups using analysis of variance (ANOVA). If it is not normally distributed, it will be presented in median and IQR and further analysed using Kruskal-Wallis test. P value \< 0.050 is considered statistically significant.

Eligibility criteria: Inclusion Criteria:

* 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:

* 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

Primary outcomes:
measure: Skin closure time
timeFrame: Day 0
Secondary outcomes:
measure: Parents' satisfaction
timeFrame: Day 7 and 1 month post operation
measure: Post operative mental health (Post operative pain)
timeFrame: Day 1 to day 7
measure: Post operative mental health (Patient's fear towards wound management post operation)
timeFrame: Day 0 and day 7
measure: Wound cosmesis
timeFrame: Day 7 and 1 month post operation
measure: Wound complication
timeFrame: Day 7 and 1 month post operation
Other outcomes:
Locations:
city: Cheras
country: Malaysia
facility: HUKM
state: Kuala Lumpur
Study officials:
affiliation: HUKM
name: Marjimin Binti Osman
role: PRINCIPAL_INVESTIGATOR
References: