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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Synthetic Electrospun Fiber Matrix | Device | Patients who are eligible for enrollment will be treated with Synthetic Electrospun Fiber Matrix immediately after surgical resection to the resulting wound |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Weekly assessments until granulation achieved or up to 6 weeks following resection surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Until healed or until 16 weeks post resection |
| Patient pain |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | At the time of complete wound closure and at the 6 month post-resection follow up |
| Infection rate and severity |
Inclusion Criteria:
Exclusion Criteria:
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Patients will be enrolled in a University Hospital Setting
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Matthew MacEwan, PhD | Contact | 440-477-1890 | macewan@acera-surgical.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Nevada - Las Vegas | Recruiting | Las Vegas | Nevada | 89102 | United States |
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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 |
| 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) | 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 | 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 | 1 week after tissue flap procedure |
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 |
| to be assessed at each visit for up to 6 months post resection |
| 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 | To be assessed at each post skin graft visit for up to 6 months post-resection |
| Tissue flap failure | Incidence of complete flap necrosis or need for total flap removal in patients who receive a tissue flap | Each post-flap follow up visit for up to 6 months post-resection |
| Incidence of local skin cancer recurrence | local recurrence of skin cancer | at the 6 month post-resection follow up |
| ID | Term |
|---|---|
| D000072836 | Surgical Wound |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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