The Deckled Incision: Study Protocol for a Randomized Controlled Trial

BACKGROUND Scar visibility is multifactorial and skin closure technique is thought to play an important role. It is an established principle in plastic surgery that Z plasties generally reduce scar contracture by breaking up the lines of tension in a wound. As an extension of this principle, it is postulated that irregular "deckled" skin incisions made during tumor excision would produce aesthetically superior scars. OBJECTIVE The primary objective of this study is to assess both the clinician and patient opinion of scar quality using the Patient and Observer Scar Assessment Scale (POSAS). Secondary objectives include the proportion of scars judged as good by the both the patient and clinician (less than or equal to 5 on the overall PSOAS scale), the number of adverse events, and the proportion of the scar visible at 1 meter. METHODS The deckling study will be a patient-blinded, simple randomized controlled trial (RCT) at a single center institution. The two groups will be equally allocated on a 1:1 ratio into the control and treatment arms. All patients greater than 18 years of age undergoing a plastic surgery procedure involving excision of skin lesions will be enrolled. Any patients requiring re-excision through the wound or undergoing injectable corticosteroid therapy will be excluded. A total of 500 patients will be enrolled. The patients will be followed-up at 1 week, 3 months, and 6 months post-operatively. RESULTS The study is expected to begin enrolment in August 2016. We anticipate that the deckling study group will have superior scar outcomes when compared to the straight line incision. From clinical experience this is especially true for lesions involving the face and in those areas of the skin that have undergone radiation therapy. The study will be funded by the Plastics and Reconstructive Surgery Department at St Vincent's Hospital, Sydney, Australia. Ethics approval has been obtained for the study. CONCLUSION We believe this will be an important study to assess a novel method to improve the appearance of post-operative scars. The deckling study is simple to master, can be applicable to almost any surgical procedure, and can have good generalizability to a large population cohort. CONCLUSIONS We believe this will be an important study to assess a novel method to improve the appearance of post-operative scars. The deckling study is simple to master, can be applicable to almost any surgical procedure, and can have good generalizability to a large population cohort. TRIAL REGISTRATION Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12616000193471; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12616000193471 (Archived by Webcite at http://www.webcitation.org/6gmG8yf1A).