A Prospective, Single-arm, Clinical Trial of Electrospun Fiber Matrix (Restrata) in the Treatment of Surgical Defects Secondary to Resection of Malignant Cutaneous Neoplasms
NCT Number: NCT06578650
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Surgical Wound
Interventions: DEVICE: Synthetic Electrospun Fiber Matrix
Sponsor: Acera Surgical, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 34
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09
Completion Date: 2025-08

Summary:
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.

Primary Outcome Measures: 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
Secondary Outcome Measures: 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, 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
Other Outcome Measures: 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, 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