ANZCTR - Registration

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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

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]

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

Wound outcomes

Condition category

Condition code

Surgery

Surgical techniques

Skin

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]

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]

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]

2 and 6 weeks after the surgery and application of the skin closure technique

Primary outcome [2]

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]

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]

Rates of wound infection

Timepoint [1]

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]

Rates of wound dehiscence

Timepoint [2]

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]

Frequency of requirement to see a healthcare practitioner due to a problem with the adhesive tape or adhesive glue

Timepoint [3]

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]

Parental concerns raised regarding the skin closure technique used

Timepoint [4]

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]

Time taken for the skin closure technique to come off

Timepoint [5]

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?

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]

Monash Medical Centre - Clayton campus - Clayton

Recruitment hospital [2]

Casey Hospital - Berwick

Recruitment postcode(s) [1]

3168 - Clayton

Recruitment postcode(s) [2]

3806 - Berwick

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Department of Paediatric Surgery, Monash Children's Hospital

Address [1]

Department of Paediatric Surgery
Monash Children's Hospital, Monash Health
246 Clayton Rd
Clayton VIC 3168

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Monash Health Human Research Ethics Committee

Ethics committee address [1]

Research Support Services
Monash Health
Level 2, I Block
Monash Medical Centre
246 Clayton Road
Clayton Victoria 3168

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

16/11/2016

Approval date [1]

08/03/2017

Ethics approval number [1]

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

Mr Ramesh Nataraja

Address

Department of Paediatric Surgery
Monash Children's Hospital
246 Clayton Road
Clayton 3168, VIC

Country

Australia

Phone

+61 3 9594 6998

Fax

Ram.Nataraja@monashhealth.org

Contact person for public queries

Name

Ramesh Nataraja

Address

Department of Paediatric Surgery
Monash Children's Hospital
246 Clayton Road
Clayton 3168, VIC

Country

Australia

Phone

+61 3 9594 6998

Fax

Ram.Nataraja@monashhealth.org

Contact person for scientific queries

Name

Ramesh Nataraja

Address

Department of Paediatric Surgery
Monash Children's Hospital
246 Clayton Road
Clayton 3168, VIC

Country

Australia

Phone

+61 3 9594 6998

Fax

Ram.Nataraja@monashhealth.org

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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

Source	Title	Year of Publication	DOI
Embase	Tissue adhesive, adhesive tape, and sutures for skin closure of paediatric surgical wounds: prospective randomized clinical trial.	2022	https://dx.doi.org/10.1093/bjs/znac254

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically