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
| NCT ID | NCT06713772 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National University of Malaysia |
| Condition | Skin Wound |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2024-08-26 |
| Primary Completion | 2025-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 90 participants in total. It began in 2024-08-26 with a primary completion date of 2025-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Marjimin Binti Osman
PRINCIPAL INVESTIGATOR
HUKM
Frequently Asked Questions
Who can join the NCT06713772 clinical trial?
This trial is open to participants of all sexes, aged 1 Day or older, up to 18 Years, studying Skin Wound. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06713772 currently recruiting?
Yes, NCT06713772 is actively recruiting participants. Visit ClinicalTrials.gov or contact National University of Malaysia to inquire about joining.
Where is the NCT06713772 trial being conducted?
This trial is being conducted at Cheras, Malaysia.
Who is sponsoring the NCT06713772 clinical trial?
NCT06713772 is sponsored by National University of Malaysia. The principal investigator is Marjimin Binti Osman at HUKM. The trial plans to enroll 90 participants.