Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000158369
Ethics application status
Approved
Date submitted
25/01/2017
Date registered
30/01/2017
Date last updated
17/12/2021
Date data sharing statement initially provided
22/03/2019
Date results information initially provided
22/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparing the results of different skin closure techniques in children after elective surgery.
Scientific title
Prospective Randomised Controlled Trial Comparing Parental Satisfaction and
Clinical Outcome Measures for Paediatric Skin Closure Techniques
Secondary ID [1] 290931 0
Nil known
Universal Trial Number (UTN)
Trial acronym
PST Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Skin closure following surgical incision 301654 0
Wound outcomes 301780 0
Condition category
Condition code
Surgery 301364 301364 0 0
Surgical techniques
Skin 301485 301485 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention Arm 1 - skin closure of surgical wound incision with adhesive glue (DERMABOND)

Patients randomised to this intervention group will have have skin closure of the surgical wound incisions with DERMABOND adhesive glue once the wound has been closed with sutures. There will be no alteration to the surgery itself. The skin incision will be closed using the DERMABOND adhesive glue by the paediatric surgeon/paediatric surgical registrar performing the operation. The DERMABOND adhesive glue is a liquid glue packaged in a ready-to-use small plastic vial with an applicator at the tip. The liquid glue is applied at the wound edge to bring the two wound edges together and hold it in place and is then left to dry for a minute or two. The approximate volume used for closing the wound incision will be determined by the treating surgeon. There is no follow-up treatment required to remove the glue itself; it will fall off after a few days. Children participating in the study as well as their parents/guardians will be told that the skin was closed with DERMABOND adhesive glue at the completion of the operation.

Intervention Arm 2 - skin closure of surgical wound incision with adhesive tape (SteriStrips)

Patients randomised to this intervention group will have have skin closure of the surgical wound incisions with adhesive tape (SteriStrips) once the wound has been closed with sutures. There will be no alteration to the surgery itself. The skin incision will be closed using the adhesive tape (SteriStrips) by the paediatric surgeon/paediatric surgical registrar performing the operation. SteriStrips are small strips of adhesive tape. The adhesive tape is applied to bring the two wound edges together and hold them in place. They are applied to the skin after the wound has been closed. The number of strips of adhesive tape required for the wound incision will be determined by the treating surgeon. There is no follow-up required to remove the SteriStrips themselves; they will fall off after a few days. Children participating in the study as well as their parents/guardians will be told that the skin was closed with adhesive tape (SteriStrips) at the completion of the operation.
Intervention code [1] 296871 0
Treatment: Surgery
Comparator / control treatment
Intervention Arm 3 - skin closure of surgical wound incision with occlusive dressing used over the top

Patients randomised to this group will have have an occlusive dressing applied over the surgical wound incisions after the wound has been closed with sutures. There will be no alteration to the surgery itself. The skin incision will be closed with sutures and the occlusive dressing placed over the top by the paediatric surgeon/paediatric surgical registrar performing the operation in order to protect and cover the wound as it heals. This dressing will be a normal waterproof occlusive dressing applied over the surgical site after the wound has been closed with stitches. For the purposes of the study, a standardised wound dressing will be used for all patients. There is no follow-up required to remove the dressing; it will come off itself after a few days. Children participating in the study as well as their parents/guardians will be told that the skin was closed with sutures and a dressing was placed over the top at the completion of the operation.
Control group
Active

Outcomes
Primary outcome [1] 300757 0
Parental satisfaction with the skin closure technique used at 2 and 6 weeks

Parents/guardians will be asked a question similar to a Likert scale where they will be asked how satisfied they were with the adhesive tape/skin glue used to close the skin incision/s. They will be given the options of 'Very Satisfied', 'Satisfied', 'Neutral', 'Dissatisfied' and 'Very Dissatisfied'.
Timepoint [1] 300757 0
2 and 6 weeks after the surgery and application of the skin closure technique
Primary outcome [2] 300758 0
Cosmetic outcome as evaluated by the child and their parents/guardians as well as a paediatric surgeon after the procedure. This outcome is assessed using a visual analogue scale completed at 2 weeks, 6 weeks and 6+ months (maximum duration of follow-up post-surgery is 36 months) after the operation completed by the child and their parents/guardians. A de-identified photograph taken of the wound at the 6 week follow-up and 6+ months after surgery will be used by the paediatric surgeon and the cosmetic outcome assessed using the Hollander Wound Evaluation Scale, Stony Brook Scar Evaluation Scale, and Visual Analogue Scale.
Timepoint [2] 300758 0
Cosmetic outcome at 2 weeks, 6 weeks and 6+ months (maximum of 36 months post-operatively) after the surgery and application of the skin closure technique as rated by the child and their parents/guardians.
Cosmetic outcome at 6 weeks and 6+ months after the surgery as rated by a paediatric surgeon blinded to the skin closure technique used
Secondary outcome [1] 330802 0
Rates of wound infection
Timepoint [1] 330802 0
Wound infection as reported by the child's parents/guardians at 2 weeks after the operation and application of the skin closure technique
Secondary outcome [2] 330803 0
Rates of wound dehiscence
Timepoint [2] 330803 0
Wound dehiscence as reported by the child's parents/guardians at 2 weeks after the operation and application of the skin closure technique
Secondary outcome [3] 330804 0
Frequency of requirement to see a healthcare practitioner due to a problem with the adhesive tape or adhesive glue
Timepoint [3] 330804 0
As reported by the child and their parents/guardians at the 2 week follow-up after the surgery and application of the skin closure technique
Secondary outcome [4] 330805 0
Parental concerns raised regarding the skin closure technique used
Timepoint [4] 330805 0
As reported by the child's parents/guardians at the 2 week follow-up after the surgery and application of the skin closure technique
Secondary outcome [5] 331097 0
Time taken for the skin closure technique to come off
Timepoint [5] 331097 0
As reported by the child's parents/guardians at the 2 week follow-up

Eligibility
Key inclusion criteria
Paediatric patients (0-18 years) presenting for an elective paediatric surgical
procedure at Monash Children's Hospital
Minimum age
No limit
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Repeat elective operations

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment will be achieved using identical opaque envelopes which will be used to randomise participating patients into one of the two intervention arms.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/03/2017
Actual
16/03/2017
Date of last participant enrolment
Anticipated
1/01/2019
Actual
15/11/2018
Date of last data collection
Anticipated
15/05/2019
Actual
10/02/2020
Sample size
Target
300
Accrual to date
Final
295
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 7328 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [2] 7329 0
Casey Hospital - Berwick
Recruitment postcode(s) [1] 15102 0
3168 - Clayton
Recruitment postcode(s) [2] 15103 0
3806 - Berwick

Funding & Sponsors
Funding source category [1] 295346 0
Hospital
Name [1] 295346 0
Department of Paediatric Surgery, Monash Children's Hospital
Country [1] 295346 0
Australia
Primary sponsor type
Hospital
Name
Department of Paediatric Surgery, Monash Children's Hospital
Address
Department of Paediatric Surgery
Monash Children's Hospital, Monash Health
246 Clayton Rd
Clayton VIC 3168
Country
Australia
Secondary sponsor category [1] 294172 0
None
Name [1] 294172 0
Address [1] 294172 0
Country [1] 294172 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296682 0
Monash Health Human Research Ethics Committee
Ethics committee address [1] 296682 0
Research Support Services
Monash Health
Level 2, I Block
Monash Medical Centre
246 Clayton Road
Clayton Victoria 3168
Ethics committee country [1] 296682 0
Australia
Date submitted for ethics approval [1] 296682 0
16/11/2016
Approval date [1] 296682 0
08/03/2017
Ethics approval number [1] 296682 0
HREC Reference Number: HREC/16/MonH/401

Summary
Brief summary
A prospective randomised controlled trial comparing skin closure of surgical incisions in children using either a wound dressing only, adhesive tape (SteriStrips) or adhesive glue (Dermabond). The choice of which of these techniques is used is usually dependent upon the surgeon’s preference and there is little evidence to show which of the three is better. This study will help to determine which of these three techniques, if any, is better and will help paediatric surgeons choose the best skin closure technique for their patients.

Parents of children presenting for elective surgical procedures will be approached for enrolment. Participating children will then be randomised to have surgical incision skin closure with sutures and then either adhesive tape, adhesive glue or a simple wound dressing.

Postoperatively, children will be followed up at 2 weeks via telephone survey where a parental satisfaction survey in terms of the wounds will be performed. Parents will also be asked questions related to:
1. Wound healing
2. The presence of any complications such as wound infection
3. Requirement to see a doctor regarding the wound postoperatively,
4. Time taken for each skin closure type to come off
5. Any parental concerns regarding the type of skin closure used.
Parents will also be asked to fill out an online survey in which they will rate the cosmetic outcome of the wound. Parents unable to be reached via telephone will have a link emailed to their email address to complete the entire survey online.

There will be a second followup at 6 weeks postoperatively where children will be reviewed by a paediatric surgeon in the Outpatients Clinic to assess the cosmetic outcome of the surgical wound and parents will be asked to complete a survey in hard-copy or on an iPad about the cosmetic outcome of the wound and overall parental satisfaction with the skin closure technique. Data collected will then be used to assess for differences between the three patient groups including blinded photographic assessment of the surgical wounds.

This project will aim to look for differences between the three groups in terms of cosmetic outcome (as rated by the parents and a blinded paediatric surgeon assessor), differences in wound infection and wound breakdown rates and a comparison of parental satisfaction with the skin closure technique.

It is hypothesised that, as all three wound closure techniques are used in clinical practice, it is likely that there will be minimal difference between the three groups. However these techniques have not been compared in a controlled trial.
Trial website
Trial related presentations / publications
Public notes
Any costs associated with this study will be met through departmental funds.

Contacts
Principal investigator
Name 71766 0
Mr Ramesh Nataraja
Address 71766 0
Department of Paediatric Surgery
Monash Children's Hospital
246 Clayton Road
Clayton 3168, VIC
Country 71766 0
Australia
Phone 71766 0
+61 3 9594 6998
Fax 71766 0
Email 71766 0
Ram.Nataraja@monashhealth.org
Contact person for public queries
Name 71767 0
Mr Ramesh Nataraja
Address 71767 0
Department of Paediatric Surgery
Monash Children's Hospital
246 Clayton Road
Clayton 3168, VIC
Country 71767 0
Australia
Phone 71767 0
+61 3 9594 6998
Fax 71767 0
Email 71767 0
Ram.Nataraja@monashhealth.org
Contact person for scientific queries
Name 71768 0
Mr Ramesh Nataraja
Address 71768 0
Department of Paediatric Surgery
Monash Children's Hospital
246 Clayton Road
Clayton 3168, VIC
Country 71768 0
Australia
Phone 71768 0
+61 3 9594 6998
Fax 71768 0
Email 71768 0
Ram.Nataraja@monashhealth.org

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Results will only be provided for overall intervention groups as per the initial statistical analysis plan, in keeping with this study's ethics approval.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseTissue adhesive, adhesive tape, and sutures for skin closure of paediatric surgical wounds: prospective randomized clinical trial.2022https://dx.doi.org/10.1093/bjs/znac254
N.B. These documents automatically identified may not have been verified by the study sponsor.