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.
Patient is at least 18 years old
Patient plans to undergo surgical resection of a cutaneous neoplasm
Patient is willing and capable of complying with all protocol requirements
Patient or legally authorized representative (LAR) is willing to provide written informed consent prior to participation in study
Inability to give informed consent or to complete the procedures required for study completion
Patient has been previously enrolled into this study, or is currently participating in another drug or device study that has not reached its primary endpoint
Patient is pregnant, breast feeding or planning to become pregnant
Patient has a known allergy to resorbable suture materials, e.g. Polyglactin 910 (PGLA), Polydioxanone (PDS)
Patients will be enrolled in a University Hospital Setting
Cohort
Prospective
Synthetic Electrospun Fiber Matrix
DevicePatients who are eligible for enrollment will be treated with Synthetic Electrospun Fiber Matrix immediately after surgical resection to the resulting wound
Time 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 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.
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 to skin grafting
Time from resection and product place until skin grafting (if patient elects to do so)
Skin graft "take" rate
Percent of skin graft incorporation as assessed by the investigator, in patients who elect to undergo skin grafting
Scar quality
Scar quality using a Vancouver Scar Scale (VSS). The scale ranges from 0 (normal skin) to 13 (worst scar outcome). Lower scores are indicative of a better scar outcome
Infection rate and severity
Incidence and severity of wound bed infection (if one occurs) per CTCAE V5.0 definitions ranging from 1 (localized, local intervention indicated) to 5 (death). Lower scores are indicative of milder infections
Skin Graft Failure
Incidence of inadequate skin graft adherence to the underlying wound bed as assessed by the investigator in patients who have received a skin graft
Tissue flap failure
Incidence of complete flap necrosis or need for total flap removal in patients who receive a tissue flap
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