Aesthetic and Functional Efficacy of Poliglecaprone 25 vs Polyglactin 910 in Running Subcuticular Closures: a Split-scar, Rater-blinded Randomized Controlled Trial

Screening: Patients will be recruited for the study after the need for excision of cutaneous malignancy has been been determined by biopsy. Patients who meet inclusion and exclusion criteria (please refer to section 11.1) will be offered to have an elliptical excision with repair by standard of care (surgeon's choice of closure of entire surgical wound) or be enrolled in the study. Patients will be recruited directly by the PI and/or co-investigators, typically on the telephone when biopsy results of cutaneous malignancy and the need for treatment by excision are being conveyed. Occasionally the patient's may be recruited directly in-person if a subsequent office-visit occurs between the patient and the physician. Patient's who enroll in the study will then undergo intervention with excision and repair at a time convenient to them, ideally within one month.

Intervention:

Patients will undergo a medically-necessary elliptical excision of their cutaneous malignancy using standard excision protocol. This will occur in a similar time frame to a standard excision of cutaneous malignancy in our clinics ranging from 1-4 weeks from diagnosis, based on the patient's preference and schedule. The wound will be divided into halves designated as side A (either left or superior aspect) and side B (either right or inferior). Side A of the wound will be randomly assigned subcuticular closure with either poliglecaprone 25 or polyglactin 910. Side B will receive the opposite of side A. Randomization will be performed with online randomization software (https://www.randomizer.org). Prior to placement of the superficial subcuticular sutures, both sides of the wound will receive vertical deep sub-epidermal sutures using polyglactin 910. Patients will be blinded as to which material is used on which side. After the wound is closed, a de-identified photograph will be taken by the PI or co-investigators of the wound with demarcation of sites A and B (using a surgical pen) to serve as a marker for side A and side B for future identification of the intervention sites. The type of randomized intervention to site A and site B will be recorded without identifying patient information on a secure, encrypted database. Closed wounds will be treated with standard protocol with a pressure bandage left in place for 24 hours followed by daily treatment with petrolatum ointment and a bandage for 2 weeks until the epidermis has healed together completely. Patients will be counseled on standard wound care as well as common complications of standard excisions by the surgeon. No visit for suture removal will be necessary as all sutures are dissolvable.

*note - interventional methods for patients included in the study are considered standard therapy. Patient's would still receive similar excision and closure of their wound if they were not participating in the research.

Follow-up: