Cosmetics, Suture, Cicatrix Clinical Trial
Official title:
Aesthetic and Functional Efficacy of Poliglecaprone 25 vs Polyglactin 910 in Running Subcuticular Closures: a Split-scar, Rater-blinded Randomized Controlled Trial
We will be recruiting patients requiring excisions of skin cancer and comparing aesthetic and functional differences of suture repair of excisional defects using polyglactin 910 vs poliglecaprone 25 with a split-scar model. Excision sites will be on either the trunk or extremities. Standard dermatological excision and repair methods will be used for removal of lesions and repair of the wound by surgeons; training courses will be used to limit inter-surgeon variation in technique. Excisional defects will be repaired with deep polyglactin 910 sutures, followed by randomly assigned subcuticular closure of one half of the defect with polyglactin 910 sutures and the other half with poliglecaprone 25 sutures. The patient will follow-up at 6 months and fill out a patient self-assessment evaluation survey of the scar. Photographs will also be taken of the scars at the follow-up at 6 months, which will be then be assigned to a set of blinded observers to evaluate the wound using a modified Patient Observer Self-Assessment Scale (mPOSAS). These observers will rate each scar on the mPOSAS scale and values will be averaged between observers. Total duration of participation will be 6 months, with 2 total visits (excision visit and follow-up visit).
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:
Patients will be called via telephone by either the PI or co-investigators after 2 weeks to
inquire about the healing process and assess for any complications.
Patients will then follow up at 6 months for their scheduled routine skin cancer
surveillance exam with the surgeon who performed the excision. At that time, the surgeon
will re-identify sites A and B with a surgical marking pen. A de-photograph will be taken of
the excision site scar. At the end of the patient visit, the patient will personally given a
POSAS patient survey and asked to rate their scar for both sites A and B; no identifying
information will be included in this survey. In the case that the scar is in a location that
the patient can not easily visualize, the de-identified photograph of the patient's scar
will be printed for the patient to assess the scar. Photographs will then later be assigned
to two blinded observers to assign a modified observer POSAS score to subjects' scars. These
scores will be averaged and then analyzed for differences.
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