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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
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
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

Study type
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

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.

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
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
Children, pregnant women, those unable to consent.

Study design
Purpose of the study
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
Other design features
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285156 0
Self funded/Unfunded
Name [1] 285156 0
Address [1] 285156 0
Country [1] 285156 0
Primary sponsor type
Dr Charles Douglas
The Breast Centre
Lake Maquarie Specialist Medical Centre
6-8 Sydney Street
NSW 2290
Secondary sponsor category [1] 284019 0
Name [1] 284019 0
Address [1] 284019 0
Country [1] 284019 0

Ethics approval
Ethics application status
Ethics committee name [1] 287172 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 287172 0
Locked Bag 1
New Lambton
2305 NSW
Ethics committee country [1] 287172 0
Date submitted for ethics approval [1] 287172 0
Approval date [1] 287172 0
Ethics approval number [1] 287172 0

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

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
NSW 2290
Country 17354 0
Phone 17354 0
Fax 17354 0
Email 17354 0
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
NSW 2290
Country 8282 0
Phone 8282 0
Fax 8282 0
Email 8282 0

No information has been provided regarding IPD availability
Summary results
No Results