A Prospective, Single-arm, Clinical Trial of Electrospun Fiber Matrix (Restrata) in the Treatment of Surgical Defects Secondary to Resection of Malignant Cutaneous Neoplasms
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.
Arms & interventions
- DeviceSynthetic Electrospun Fiber Matrix
Patients who are eligible for enrollment will be treated with Synthetic Electrospun Fiber Matrix immediately after surgical resection to the resulting wound
Outcome measures
Primary
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 frame: Weekly assessments until granulation achieved or up to 6 weeks following resection surgery
Secondary
Time to complete wound healing
Time frame: Until healed or until 16 weeks post resection
Patient pain
Time frame: Weekly for up to six weeks post resection
Time to skin grafting
Time frame: Weekly for up to 6 weeks post-resection
Skin graft "take" rate
Time frame: 1 week after skin graft application
Tissue flap take rate
Time frame: 1 week after tissue flap procedure
Eligibility criteria
Study locations (1)
University Nevada - Las Vegas
Las Vegas, Nevada, 89102