The goal of this observational prospective study is to evaluate wound healing outcomes in resection wounds resulting from surgical removal of cutaneous malignancies treated with a synthetic electrospun fiber matrix. This study intends to quantify the time from initial resection and product application to time of complete granulation of the wound bed in weeks.
Study Type
OBSERVATIONAL
Enrollment
34
Patients who are eligible for enrollment will be treated with Synthetic Electrospun Fiber Matrix immediately after surgical resection to the resulting wound
University Nevada - Las Vegas
Las Vegas, Nevada, United States
RECRUITINGTime to wound bed granulation
Time from initial resection and product placement to the time of at least 75% wound bed granulation using a modified Bates-Jenson Scale. The Bates-Jenson Scale for Granulation Tissue ranges from: 1=Skin intact or partial thickness wound, to: 5=No granulation tissue present. Wounds are considered "granulated" upon receiving a rating of 2 (Bright, beefy red;75% to 100% of wound filled \&/or tissue overgrowth) or less upon investigator assessment. Lower scores are indicative of better outcomes.
Time frame: Weekly assessments until granulation achieved or up to 6 weeks following resection surgery
Time to complete wound healing
Total healing time will be documented (in days) at the final follow-up appointment by calculating the difference using the resection visit and "healed" visit dates.
Time frame: Until healed or until 16 weeks post resection
Patient pain
Pain reported by patient on a Visual Analogue Scale (VAS), with 0 indicating no pain and 10 indicating worst pain possible. Lower scores are indicative of a better outcome
Time frame: Weekly for up to six weeks post resection
Time to skin grafting
Time from resection and product place until skin grafting (if patient elects to do so)
Time frame: Weekly for up to 6 weeks post-resection
Skin graft "take" rate
Percent of skin graft incorporation as assessed by the investigator, in patients who elect to undergo skin grafting
Time frame: 1 week after skin graft application
Tissue flap take rate
Percent of successful tissue graft incorporation as assessed by the investigator, in patients who elect to undergo tissue flap procedures
Time frame: 1 week after tissue flap procedure
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