RecruitingACTRN12612000500853

Type 1 Keystone Flap versus Simple Primary Closure for wound closure - A Prospective Randomised Controlled Trial

Type 1 Keystone Flap versus Simple Primary Closure for wound closure in patients undergoing surgical excision of skin lesion - A Prospective Randomised Controlled Trial


Sponsor

Dr Charles Douglas

Enrollment

200 participants

Start Date

Apr 1, 2012

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 100 Yearss

Plain Language Summary

Simplified for easier understanding

This study is comparing two methods of closing a wound after skin surgery: a standard direct closure (simply stitching the edges together) and a technique called a Type 1 Keystone Flap, which uses a different pattern of tissue movement to close the wound. Researchers want to find out if the Keystone Flap heals better than a standard closure when wounds are expected to be difficult to close. Wound healing quality will be measured using a standard scoring system. You may be eligible if: - You are 18 years of age or older - You are having surgical removal of a skin lesion where wound closure is expected to be difficult - You are able to give informed consent You may NOT be eligible if: - You are a child (under 18) - You are pregnant - You are unable to give informed consent Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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

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.


Locations(1)

Australia

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ACTRN12612000500853