Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000193471
Ethics application status
Approved
Date submitted
9/02/2016
Date registered
15/02/2016
Date last updated
15/02/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
A New Surgical Incision Method To Improving Post Operative Scars in Patients.
Scientific title
The “Deckled” Incision: A new surgical approach to improving post-operative scars.
Secondary ID [1] 288512 0
NIL
Universal Trial Number (UTN)
NIL
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post Operative Scar 297584 0
Condition category
Condition code
Cancer 297779 297779 0 0
Non melanoma skin cancer
Cancer 297801 297801 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The "Deckled" incision is new approach to the scalpel incision. It involves making a curvilinear incision and utilises W-plasty principles to lead to improve scars.
Intervention code [1] 293875 0
Treatment: Surgery
Comparator / control treatment
Straight line incision
Control group
Active

Outcomes
Primary outcome [1] 297307 0
To assess clinician opinion of scar quality using Observer component of scar scale
Timepoint [1] 297307 0
1 week post op
3 months post op
6 months post op
Primary outcome [2] 297326 0
To assess the patient’s opinion of scar quality/sensation using the Patient component of the scar scale
Timepoint [2] 297326 0
1 week post op
3 months post op
6 months post op
Secondary outcome [1] 320672 0
The proportion of scars assessed as good by the clinician (determined by less than or equal to 5 on the “Overall” component of the POSAS)
Timepoint [1] 320672 0
1 week post op
3 Months post op
6 Months post op
Secondary outcome [2] 320734 0
The proportion of scar assessed as good by the patients (determined by less than or equal to 5 on the “Overall” component of the POSAS)
Timepoint [2] 320734 0
1 week post op
3 Months post op
6 months post op
Secondary outcome [3] 320735 0
Number of adverse events overall and by individual components (namely dehiscence infection, keloids). These will be assessed at the outpatient clinics and from review of relevant medical records
Timepoint [3] 320735 0
1 week post op
3 months post op
6 months post op
Secondary outcome [4] 320769 0
The percentage of the scar visible as a percentage of the total length of the scar at 1 meter"
Timepoint [4] 320769 0
1 week post op
3 months post op
6 months post op

Eligibility
Key inclusion criteria
1 Age range: Greater than or equal to 18 years of age.
2 Able to give informed consent and willingness to participate in follow up.
3 Undergoing any plastic surgery procedure involving excision of skin lesions
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1 Those requiring re-excision through the original wound
2 Undergoing injectable corticosteroid therapy into the scar

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)
External person will notify surgeon via phone which lesions will be "Deckled" or have straight line incision. Because lesions are randomised rather than the patient, an individual patient may undergo both excision with both 'deckled' and straight line incisions.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple random number genertor
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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Independent two-sample T test, Chi-squared and Logistic Regression Analysis . A difference of 1 on the overall scar scale was deemed to be statistically significant however this may not be clinically significant. A 10% difference in the secondary analysis looking at the proportion of good overall scars was subsequently used to assess clinical significance. We anticipate a 10% attrition rate. No formal sample size calculation was performed.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2016
Actual
Date of last participant enrolment
Anticipated
1/08/2017
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 5253 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst

Funding & Sponsors
Funding source category [1] 292860 0
Hospital
Name [1] 292860 0
St Vincent's Hospital, Plastics and Reconstructive Surgery Department
Country [1] 292860 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital
Address
390 Victoria St
Darlinghurst, 2010
NSW
Country
Australia
Secondary sponsor category [1] 291606 0
None
Name [1] 291606 0
Address [1] 291606 0
Country [1] 291606 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294359 0
St Vincent's Hospital Sydney Human Research Ethics Committee (HREC)
Ethics committee address [1] 294359 0
390 Victoria St
Darlinghurst, 2010
NSW
Ethics committee country [1] 294359 0
Australia
Date submitted for ethics approval [1] 294359 0
01/04/2015
Approval date [1] 294359 0
31/07/2015
Ethics approval number [1] 294359 0
HREC/14/SVH/132

Summary
Brief summary
This study aims to evaluate if whether using the “Deckled” incision improves post-operative scars compared to the standard straight line incision in people undergoing surgery for skin lesions. Who is it for? You may be eligible to join this study if you are aged 18 years or more and are scheduled to undergo any plastic surgery procedure involving excision of skin lesions. Study details Participants in this study will be randomly allocated (by chance) to one of two groups in an equal ratio. Participants will not be aware of the group/treatment they have been allocated to receive. For patients with multiple lesions, because each lesion is randomised, they may have both the "Deckled" incision or straight line incision performed. This study will help determine if “Deckled” incision has superior scar outcomes compared to the straight line incision approach.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 63426 0
Dr Elias Moisidis
Address 63426 0
St Vincent's Hospital, Department of Plastics and Reconstructive Surgery
390 Victoria St
Darlinghurst, NSW 2010
Country 63426 0
Australia
Phone 63426 0
+612 8382 1111
Fax 63426 0
Email 63426 0
[email protected]
Contact person for public queries
Name 63427 0
Dr Apresh Singla
Address 63427 0
St Vincent's Hospital, Department of Plastics and Reconstructive Surgery
390 Victoria St
Darlinghurst, NSW 2010
Country 63427 0
Australia
Phone 63427 0
+61412258889
Fax 63427 0
Email 63427 0
[email protected]
Contact person for scientific queries
Name 63428 0
Dr Apresh Singla
Address 63428 0
St Vincent's Hospital, Department of Plastics and Reconstructive Surgery
390 Victoria St
Darlinghurst, NSW 2010
Country 63428 0
Australia
Phone 63428 0
+61412258889
Fax 63428 0
Email 63428 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
No additional documents have been identified.