Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000168752
Ethics application status
Not yet submitted
Date submitted
8/02/2013
Date registered
12/02/2013
Date last updated
12/02/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparing the scar healing of skin cuts in children when using stitches under versus on the skin
Scientific title
Comparison of cosmetic outcomes when using buried versus external suturing techniques in children
Secondary ID [1] 281926 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lacerations 288330 0
Condition category
Condition code
Injuries and Accidents 288680 288680 0 0
Other injuries and accidents
Surgery 288695 288695 0 0
Surgical techniques
Skin 288696 288696 0 0
Normal skin development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Buried suturing technique using buried interrupted and/or subcuticular sutures. 15 minute procedure performed once to close laceration.
Intervention code [1] 286489 0
Treatment: Surgery
Comparator / control treatment
External suturing technique using external continuous or interrupted sutures. 15 minute procedure performed once to close laceration.
Control group
Active

Outcomes
Primary outcome [1] 288831 0
Cosmetic outcome.
Assessed using the previously validated Patient and Observer Scar Assessment Scale (POSAS). Lacerations will be assigned a 1 to 10 point in each criterion. Investigators will use the observer section to assess the vascularity, pigmentation, relief, pliability, surface area and overall opinion of the scar using this scale. Parents and adolescents (age, >15 years) will be asked a series of seven questions using this scale and consideration of using the specific suture technique in the future. The presence of a keloid scar and the width of the scar will also be measured to the nearest millimetre in its widest dimension will also be noted.
Timepoint [1] 288831 0
3 months
Secondary outcome [1] 301083 0
Wound infection.
During the follow-up visit, the wound will be evaluated for the presence of “wound infection” which is defined as one that requires systemic antibiotics as determined by the treating clinician.
Timepoint [1] 301083 0
Single time point, a follow-up visit within 5 to 8 days after the procedure.
Secondary outcome [2] 301084 0
Wound dehiscence.
During the follow-up visit, the wound will be evaluated for the presence of “wound dehiscence” which is defined present if the wound edges are not coapted and require the placement of additional sutures or tissue adhesives.
Timepoint [2] 301084 0
Single time point, a follow-up visit within 5 to 8 days after the procedure.

Eligibility
Key inclusion criteria
Non-gaping, linear laceration.
Has a legally acceptable representative capable of understanding the informed consent document and providing consent of the subject's behalf
Minimum age
1 Years
Maximum age
19 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Allergy to suture material
Known personal or family history of keloid formation or hypertrophic scars
Bleeding or clotting disorder
Laceration as a result of a mammalian bite
Laceration can be repaired with the application of topical adhesive
Wound involving deep vital structures

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 286713 0
Hospital
Name [1] 286713 0
Western Health
Country [1] 286713 0
Australia
Primary sponsor type
Individual
Name
Wai-Ting Choi
Address
Department of Plastic and Reconstructive Surgery
Western Hospital
Gordon Street
Footscray
3011 Victoria
Country
Australia
Secondary sponsor category [1] 285485 0
Individual
Name [1] 285485 0
Xin Lyn Goh
Address [1] 285485 0
Western Clinical School
NorthWest Academic Centre
The University of Melbourne
Sunshine Hospital
(PO Box 294)
176 Furlong Road
St Albans
3021 Victoria
Country [1] 285485 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 288779 0
RCH Human Research Ethics Committee
Ethics committee address [1] 288779 0
Research Development & Ethics
The Royal Children's Hospital
Level 2 East, Zone K
50 Flemington Road
Parkville Vic 3052
Ethics committee country [1] 288779 0
Australia
Date submitted for ethics approval [1] 288779 0
21/01/2013
Approval date [1] 288779 0
Ethics approval number [1] 288779 0
32273A

Summary
Brief summary
Skin cuts are common injuries sustained by children. There are two main to stitch cuts. The first method is to use stiches on the outside of the skin and the other method is to use a deeper stitch that would not be able to be seen on the skin surface. The purpose of this project is to study whether one of these two methods of stitching results in better healings of cuts.

We do not know whether one method of closing facial skin cuts is better than the other. Both methods have their advantages and disadvantages. Stitches under the skin (or buried stitches) provide good support for facial wound closure while stiches on the skin (external stitches) have a lower risk of complications but may result in a more visible scar. Previous research studies on adults have found that the both buried and external stiches have healed in a similar fashion
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 37738 0
Mr Wai-Ting Choi
Address 37738 0
Department of Plastic and Reconstructive Surgery
Western Hospital
Gordon Street
Footscray
3011 Victoria
Country 37738 0
Australia
Phone 37738 0
+1 3 8345 6666
Fax 37738 0
Email 37738 0
[email protected]
Contact person for public queries
Name 37739 0
Ms Xin Lyn Goh
Address 37739 0
Western
 Clinical
 School
  NorthWest
 Academic
 Centre
The University of Melbourne
Sunshine Hospital
(PO Box 294)
176 Furlong Road
St Albans
3021 Victoria
Country 37739 0
Australia
Phone 37739 0
+1 3 80606464
Fax 37739 0
Email 37739 0
[email protected]
Contact person for scientific queries
Name 37740 0
Ms Xin Lyn Goh
Address 37740 0
The University of Melbourne
Sunshine Hospital
(PO Box 294)
176 Furlong Road
St Albans
3021 Victoria
Country 37740 0
Australia
Phone 37740 0
+1 3 80606464
Fax 37740 0
Email 37740 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

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

Documents added automatically
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