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Trial registered on ANZCTR


Registration number
ACTRN12618000419268p
Ethics application status
Submitted, not yet approved
Date submitted
19/02/2018
Date registered
22/03/2018
Date last updated
22/03/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of absorbable deep dermal versus nonabsorbable interrupted sutures in emergency department wound closure in a paediatric randomised controlled trial study
Scientific title
Comparison of absorbable deep dermal versus nonabsorbable interrupted sutures in emergency department wound closure in a paediatric randomised controlled trial study
Secondary ID [1] 294054 0
Nil known
Universal Trial Number (UTN)
U1111-1209-5572
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Wound lacerations 306656 0
Condition category
Condition code
Injuries and Accidents 305757 305757 0 0
Other injuries and accidents
Skin 305758 305758 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will analyse Vicryl Rapide (absorbable) versus non­absorbable Nylon sutures in the closure of wounds in the emergency department setting.
Participants receiving absorbable sutures will have their wounds closed by the deep dermal wound closure technique. This involves inserting the suture first from deep within the wound, from one edge and exiting  just under the epidermis. The same suture is inserted from the opposite edge under the epidermis and exit deep within the wound. The stitch is then tied with the knot buried deep in the wound. This is repeated in an interrupted fashion till the wound is completely closed.
We estimate that most wounds will be closed in 20 minutes, depending on the type of wound in sustained by the participant, whether it requires cleaning, how settled the child is.
Emergency department staff will be briefed on what this study involves, and those wishing to participate will do so. Doctors (excluding interns) working in the emergency department will complete the suturing. Nursing staff will assess the wound at follow-up visits. The wound will be bandaged up to 7 days after the wound closure. This is to ensure that the parents are blinded in regards to the types of interventions performed.
Participants and their parents/guardians will be reminded by phone calls and/or text messages to attend their follow-up appointments. Staff at the appointments will remind them of the study requirements (e.g. do not wash the wound themselves), and all participants are provided with contact information of the investigators should they have questions throughout the study.
The child participant will then be asked to return to an assigned clinic 3 days, 7 days and 3 months after the initial presentation. Here, wounds will be assessed and checked by staff for infection and stitches may be removed (this may require anaesthesia or sedation). Three months later, the scar from the wound will be photographed, and medical staff will be asked to rate the appearance of the scar.
Intervention code [1] 300362 0
Treatment: Surgery
Intervention code [2] 300534 0
Treatment: Devices
Comparator / control treatment
This is randomised double blinded comparative study on the use of absorbable Vicryl Rapide versus non­ absorbable Nylon sutures in the closure of wounds in the emergency department setting.
The non absorbable Nylon sutures is the control treatment group
Control group
Active

Outcomes
Primary outcome [1] 304830 0
Wound infection. We plan to utilise Bates-Jenson Wound Assessment Tool to assess wound infection rates. This will be performed by staff who assess patients at follow-up appointments. Participants who report signs of infection in the interim are able to be assessed earlier than their next scheduled appointment.
Timepoint [1] 304830 0
3 days, 7 days (primary timepoint) and 3 months after the initial presentation (secondary timepoint)
Secondary outcome [1] 343324 0
Time for wound closure: this will be noted by staff who assess patients at follow-up appointments at day 7.
Timepoint [1] 343324 0
7 days after initial presentation. Staff will assess wound closure by utilising the Bates-Jenson Wound Assessment Tool. If the wound is not closed by day 7, patients will attend a follow-up appointment on day 14 and/or day 21 if the wound is still not closed by day 14. (as this tool is designed for weekly monitoring).
Secondary outcome [2] 344284 0
Wound dehiscence: this will be noted by staff who assess patients at follow-up appointments. At each appointment, staff will be provided with the Bates-Jenson Wound Assessment Tool to assess wound dehiscence. If wound dehiscence is present, a second set of sutures will be inserted and the patient will be asked to return for further assessment on day 14.
Timepoint [2] 344284 0
7 days after initial presentation. Staff will assess wound closure by utilising the Bates-Jenson Wound Assessment Tool. If the wound is found to have dehiscence by day 7, it will be closed by another suture. Patients will attend a follow-up appointment on day 14 (as this tool is designed for weekly monitoring).
Secondary outcome [3] 344285 0
Economic cost: direct cost of materials used for each patient
Timepoint [3] 344285 0
3 months after the initial presentation
Secondary outcome [4] 344286 0
Cosmetic appearance: photo taken of the wound 3 months after the initial emergency presentation. These photos will be separately rated by 3 physicians who are blinded to the treatment groups using a previously validated visual analogue scale, which rates the appearance of the scar out of 100.
Timepoint [4] 344286 0
3 months after the initial presentation

Eligibility
Key inclusion criteria
Children between the ages of 1 year and 17 years.
Single laceration in a child in the above age bracket.
Lacerations located on any region of the body.
Laceration lengths between 1cm and 5cm.
Lacerations considered suitable for suturing.
Minimum age
1 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children or parent/carer who decline to be part of the study.
Children who elect to have their surgery done outside the ED.
Children whose wounds need to be closed by non-ED staff.
Children who have chronic medical conditions that may impact the wound healing process. This includes type one and two diabetes mellitus, heart failure, patients who are taking immunosuppresives or have bleeding disorders.
Children who came in with multiple lacerations or deep lacerations affecting the underlying structures such as ligaments and neurovascular supplies.
Children who have severe needle phobia.
Children who will struggle to attend outpatient appointments due to logistic issues.

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)
Each patient will be randomly assigned to the absorbable Vicryl group or the Non­absorbable Nylon group by a computer generated random number selection.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table will be created by computer generated random number selection.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Factorial
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We will randomly select 112 number of children between the ages of 1 year and 17 years.
Each patient will be randomly assigned to the absorbable Vicryl group or the Non­absorbable Nylon group by a computer generated random number selection.
The patients and their parents or carers will be blinded to the type of suture used in the wound closure. The assessors of the scars will also be blinded to type of sutures used for wound closure.
We intend to employ a biostatistician to complete power calculations and statistical analysis for our study.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2018
Actual
Date of last participant enrolment
Anticipated
30/04/2019
Actual
Date of last data collection
Anticipated
30/07/2019
Actual
Sample size
Target
112
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 10058 0
Albury Wodonga Health - Albury campus - Albury
Recruitment hospital [2] 10059 0
Frankston Hospital - Frankston
Recruitment hospital [3] 10060 0
The Children's Hospital at Westmead - Westmead
Recruitment hospital [4] 10061 0
Gosford Hospital - Gosford
Recruitment postcode(s) [1] 21575 0
2640 - Albury
Recruitment postcode(s) [2] 21576 0
3199 - Frankston
Recruitment postcode(s) [3] 21577 0
2145 - Westmead
Recruitment postcode(s) [4] 21578 0
2250 - Gosford

Funding & Sponsors
Funding source category [1] 298717 0
Hospital
Name [1] 298717 0
Albury Wodonga Health
Country [1] 298717 0
Australia
Funding source category [2] 299017 0
Hospital
Name [2] 299017 0
Frankston Hospital
Country [2] 299017 0
Australia
Funding source category [3] 299018 0
Hospital
Name [3] 299018 0
The Children's Hospital at Westmead
Country [3] 299018 0
Australia
Funding source category [4] 299019 0
Hospital
Name [4] 299019 0
Gosford Hospital
Country [4] 299019 0
Australia
Primary sponsor type
Individual
Name
Dr Gabriel Akra
Address
Albury Hospital
201 Borella Road, Albury 2640, NSW.
Country
Australia
Secondary sponsor category [1] 297891 0
None
Name [1] 297891 0
Address [1] 297891 0
Country [1] 297891 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 299634 0
Monash Health Human Research Ethics Committee
Ethics committee address [1] 299634 0
Ethics committee country [1] 299634 0
Australia
Date submitted for ethics approval [1] 299634 0
01/03/2018
Approval date [1] 299634 0
Ethics approval number [1] 299634 0
Ethics committee name [2] 299664 0
Albury Wodonga Human Research Ethics Committee (EC00117)
Ethics committee address [2] 299664 0
Ethics committee country [2] 299664 0
Australia
Date submitted for ethics approval [2] 299664 0
01/06/2017
Approval date [2] 299664 0
Ethics approval number [2] 299664 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 81110 0
Miss Alice Grimshaw
Address 81110 0
Albury Wodonga Health
201 Borella Rd, Albury NSW 2640
Country 81110 0
Australia
Phone 81110 0
+61427113735
Fax 81110 0
Email 81110 0
[email protected]
Contact person for public queries
Name 81111 0
Gabriel Gbesimi Akra
Address 81111 0
Albury Wodonga Health
201 Borella Rd, Albury NSW 2640
Country 81111 0
Australia
Phone 81111 0
+61421926507
Fax 81111 0
Email 81111 0
[email protected]
Contact person for scientific queries
Name 81112 0
Gabriel Gbesimi Akra
Address 81112 0
Albury Wodonga Health
201 Borella Rd, Albury NSW 2640
Country 81112 0
Australia
Phone 81112 0
+61421926507
Fax 81112 0
Email 81112 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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