Skin WoundNCT06713772
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
A study testing Dermabond Mini, 0.36ml, Ethicon Johnson and Johnson, Somerville, New Jersey, USA, Steri-StripsTM (3M, St. Paul, Minnesota, USA and Monosyn, B.Braun, 118 Pfieffewiesen, Melsungen, Germany in people with Skin Wound, run by National University of Malaysia at 1 site in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Skin Wound
- What is being tested?
- Dermabond Mini, 0.36ml, Ethicon Johnson and Johnson, Somerville, New Jersey, USA, Steri-StripsTM (3M, St. Paul, Minnesota, USA and Monosyn, B.Braun, 118 Pfieffewiesen, Melsungen, Germany
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteMalaysia
- Study dates
- 26 Aug 2024to 31 May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Malaysia1 site, 1 recruiting
- Recruiting
HUKM
Cheras, Kuala Lumpur, 56000
Marjmin Binti Osman, +60192773550, marjmin@gmail.com
Marjimin Binti Osman
About this study
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
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.
Read more
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.
Read the 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.
- Conditions
- Skin Wound
- Being tested
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dermabond Mini, 0.36ml, Ethicon Johnson and Johnson, Somerville, New Jersey, USADevice
Dermabond Mini, 0.36ml, Ethicon Johnson and Johnson, Somerville, New Jersey, USA
Steri-StripsTM (3M, St. Paul, Minnesota, USADevice
Steri-StripsTM (3M, St. Paul, Minnesota, USA
Monosyn, B.Braun, 118 Pfieffewiesen, Melsungen, GermanyDevice
Monosyn, B.Braun, 118 Pfieffewiesen, Melsungen, Germany
| Study group | Role | What they receive |
|---|---|---|
| Group A - Adhesive glue | Active comparator | Dermabond Mini, 0.36ml, Ethicon Johnson and Johnson, Somerville, New Jersey, USA Receives: Device: Dermabond Mini, 0.36ml, Ethicon Johnson and Johnson, Somerville, New Jersey, USA |
| Group B - Adhesive tape | Active comparator | Steri-StripsTM (3M, St. Paul, Minnesota, USA Receives: Device: Steri-StripsTM (3M, St. Paul, Minnesota, USA |
| Group C - Suture | Active comparator | Monosyn, B.Braun, 118 Pfieffewiesen, Melsungen, Germany Receives: Device: Monosyn, B.Braun, 118 Pfieffewiesen, Melsungen, Germany |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 0
Secondary outcomes (5)
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
Measured: 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.
Measured: Day 1 to day 7
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
Measured: Day 0 and day 7
Wound cosmesis
Cosmetic appearance of skin will be assessed by using the Vancouver Scar Scale on the day 7 and 1 month
Measured: Day 7 and 1 month post operation
Wound complication
Wound complication will be assessed using ASEPSIS Score on the day 7 and 1 month post operation
Measured: Day 7 and 1 month post operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2024
- Study start26 Aug 2024
- Primary completion31 Mar 2025 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin WoundStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marjimin Binti Osman, Principal investigator, HUKM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06713772
- Sponsor's protocol ID
- FF-2024-290
- Status last verified
- Nov 2024
- First submitted
- 12 Aug 2024
- Last updated
- 3 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06713772
- Acronym / sponsor ID
- FF-2024-290
- Conditions
- Skin Wound
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- National University of MalaysiaUniversity, hospital or other
- Study start
- 26 Aug 2024 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 3 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A - Adhesive glue | Active comparator | Device: Dermabond Mini, 0.36ml, Ethicon Johnson and Johnson, Somerville, New Jersey, USADermabond Mini, 0.36ml, Ethicon Johnson and Johnson, Somerville, New Jersey, USA |
| Group B - Adhesive tape | Active comparator | Device: Steri-StripsTM (3M, St. Paul, Minnesota, USASteri-StripsTM (3M, St. Paul, Minnesota, USA |
| Group C - Suture | Active comparator | Device: Monosyn, B.Braun, 118 Pfieffewiesen, Melsungen, GermanyMonosyn, B.Braun, 118 Pfieffewiesen, Melsungen, Germany |
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dermabond Mini, 0.36ml, Ethicon Johnson and Johnson, Somerville, New Jersey, USADermabond Mini, 0.36ml, Ethicon Johnson and Johnson, Somerville, New Jersey, USA | Device | Group A - Adhesive glue |
| Steri-StripsTM (3M, St. Paul, Minnesota, USASteri-StripsTM (3M, St. Paul, Minnesota, USA | Device | Group B - Adhesive tape |
| Monosyn, B.Braun, 118 Pfieffewiesen, Melsungen, GermanyMonosyn, B.Braun, 118 Pfieffewiesen, Melsungen, Germany | Device | Group C - Suture |
Primary outcome
Skin closure time
Time frame: 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
5 secondary outcomes
Parents' satisfaction
Time frame: Day 7 and 1 month post operation
Post operative mental health (Post operative pain)
Time frame: Day 1 to day 7
Post operative mental health (Patient's fear towards wound management post operation)
Time frame: Day 0 and day 7
Wound cosmesis
Time frame: Day 7 and 1 month post operation
Wound complication
Time frame: Day 7 and 1 month post operation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marjimin Binti Osman principal investigator
HUKM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dermabond Mini, 0.36ml, Ethicon Johnson and Johnson, Somerville, New Jersey, USA, Steri-StripsTM (3M, St. Paul, Minnesota, USA and Monosyn, B.Braun, 118 Pfieffewiesen, Melsungen, Germany in people with Skin Wound, run by National University of Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin closure time (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2024; AzTrials last refreshed its copy on 6 Nov 2026.