Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12612000500853
Ethics application status
Approved
Date submitted
24/04/2012
Date registered
9/05/2012
Date last updated
9/05/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Type 1 Keystone Flap versus Simple Primary Closure for wound closure - A Prospective Randomised Controlled Trial
Scientific title
Type 1 Keystone Flap versus Simple Primary Closure for wound closure in patients undergoing surgical excision of skin lesion - A Prospective Randomised Controlled Trial
Secondary ID [1] 280386 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Wound closure of difficult surgical defects 286369 0
Condition category
Condition code
Surgery 286611 286611 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Type 1 Keystone flap as described by F Behan. A type of Perforator island flap - that is a tissue island which is separated from surrounding skin and hence relies on deep perforating vessels for it's blood supply. It is essentially elliptical in shape with its long axis adjacent to the long axis of the defect. The flap is based on randomly located vascular perforators. The wound is closed directly, the mid-line area is the line of maximum tension and by V-Y advancement of each end of the flap, the ‘islanded’ flap fills the defect. This allows the secondary defect on the opposite side to be closed, exploiting the mobility of the adjacent surrounding tissue. The technique can be found in the book 'The Keystone Perforator Island Flap Concept' by Felix Behan (Churchill Livingstone Australia,
ISBN: 9780729539715. Approximate duration is 30-60 minutes.
Intervention code [1] 284751 0
Treatment: Surgery
Comparator / control treatment
Simple primary wound closure. Eliptical excision of lesion with approximation of two edges and closure with simple sutures. Duration is approximately 20-40 minutes.
Control group
Active

Outcomes
Primary outcome [1] 287022 0
ASEPSIS wound score. This is a previously validated post-operative wound score which measures erythema, wound discharge, use of antibiotics, re-operation/drainage, and separation to provide an overall score on which wound healing can be judged and compared.
Timepoint [1] 287022 0
Post-operatively at one, two, and four weeks. Again at six months.
Secondary outcome [1] 297225 0
Visual analogue pain score.
Timepoint [1] 297225 0
Post-operatively at one, two, and four weeks. Again at six months
Secondary outcome [2] 297345 0
Cosmesis score - photographs judged by patients and non-medical volunteers
Timepoint [2] 297345 0
Post-operatively at one, two, and four weeks. Again at six months.

Eligibility
Key inclusion criteria
Patients undergoing surgical excision of skin lesion of which closure is suspected to be difficult. Intra-operative tension measurements will be taken and patients then stratified into tension-level groups for analysis.
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children, pregnant women, those unable to consent.

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)
Patients attending clinic will be assessed for suitability. Consent will be obtained at this time. Randomisation will occur at the time of surgery once excision has occurred. The computer generated randomisation schedule is kept by a third person not involved with the study who will provide allocation arms upon request.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated block randomisation with random block sizes.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/04/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285156 0
Self funded/Unfunded
Name [1] 285156 0
Country [1] 285156 0
Primary sponsor type
Individual
Name
Dr Charles Douglas
Address
The Breast Centre
Lake Maquarie Specialist Medical Centre
6-8 Sydney Street
Gateshead
NSW 2290
Country
Australia
Secondary sponsor category [1] 284019 0
None
Name [1] 284019 0
Address [1] 284019 0
Country [1] 284019 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287172 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 287172 0
HNEHREC
Locked Bag 1
New Lambton
2305 NSW
Ethics committee country [1] 287172 0
Australia
Date submitted for ethics approval [1] 287172 0
Approval date [1] 287172 0
02/03/2012
Ethics approval number [1] 287172 0
12/02/15/4.04

Summary
Brief summary
Surgical defeects that are predicted to be difficult to close may be considered for type one ketstone closure. The
theoretical advantage of this method is that the release of the longitudinal tension in the wound allows greater
stretch along the transverse axis. There is no reliable evidence in the literature to prove that this is the case in
human models, indeed in our small study the increase in transverse stretch enabled by longitudinal release was
less than 1mm. With this in mind the advantage of a keystone flap over other wound closure techniques is unclear.
We aim to compare the keystone flap with simple primary wound closure, with primary outcome measured as
wound healing, using the ASEPSIS wound score. The type one keystone flap was first described by Behan in
2003, for use in "suitable defects over most areas of the body up to 2cm in width". Patients will be recruited into the
study based upon this selction criteria and then randomised to keystone flap or primary closure. Short and longterm
follow up centered around the ASEPSIS wound score will be used to compare wound healing in the two groups.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34107 0
Address 34107 0
Country 34107 0
Phone 34107 0
Fax 34107 0
Email 34107 0
Contact person for public queries
Name 17354 0
Dr Charles Douglas
Address 17354 0
The Breast Centre
Lake Maquarie Specialist Medical Centre
6-8 Sydney Street
Gateshead
NSW 2290
Country 17354 0
Australia
Phone 17354 0
+610249424600
Fax 17354 0
Email 17354 0
[email protected]
Contact person for scientific queries
Name 8282 0
Dr Charles Douglas
Address 8282 0
The Breast Centre
Lake Maquarie Specialist Medical Centre
6-8 Sydney Street
Gateshead
NSW 2290
Country 8282 0
Australia
Phone 8282 0
+610249424600
Fax 8282 0
Email 8282 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.