Silicone Taping for the Improvement of Abdominal Donor Site Scars Following Autologous Breast Reconstruction; A Randomized, Prospective Controlled Trial

This is a prospective, single center, masked, randomized self-controlled clinical human trial to evaluate the appearance of abdominal scars after autologous free-flap breast reconstruction following post-operative application of silicone tape to improve scar quality. Incisions from 32 adult subjects will act as their own control and will be randomized to have silicone tape applied to one half of their abdominoplasty incision and control treatment using the current standard of care at the investigators institution to the other half, which is no dressing after the initial two week post-op period. A participant size of 32 leaves room in case of participant loss to follow-up, ensuring data will be available for the required sample size of 28 (see statistical analysis section below). A random number sequence generator will be used to randomize which half of the patient's wound will receive the treatment.

Patients will be recruited from plastic surgery clinics at the Queen Elizabeth II (QEII) Health Sciences Centre in Halifax, Nova Scotia. Plastic surgeons will be asked to participate and enroll their breast reconstruction patients, who will undergo a type of abdominoplasty as part of their reconstruction procedure.

Patients will undergo a de novo abdominoplasty procedure as part of a reconstructive breast surgery. Two weeks post-operatively, one side of the patient's abdominoplasty incision will be randomized to receive the silicone tape and the remaining half will be left to heal without any dressing application, which is the current standard at the investigators institution. Each patient will act as their own control. Patients will apply silicone tape on a daily basis, with each piece lasting 24 hours. Tape may be removed for showers and replied after drying. Total length of treatment will be two and a half months.

It is not possible to mask patients, as they will be responsible for ongoing application of the silicone tape. However, the staff surgeon will be masked. Patients will present to their first post-op visit at two weeks. After examination by the staff surgeon, the patient will be seen by the research coordinator who will provide the patient with their randomization treatment assignment. To ensure ongoing masking, at subsequent follow-up visits, patients will remove their dressings one day prior to their appointment with their surgeon. This will ensure no local reaction (i.e. redness after tape removal) that would compromise the masking of staff surgeons.

Patients will then follow up for scar assessment at 6 weeks, 3 months, 6 months and 12 months. Unless otherwise required, scar assessments will then be performed at each visit by both the patient and the surgeon using validated objective and subjective scar measures. Patients will also meet with the research coordinator at each follow up visit, to address any questions or concerns about the study and treatment.