Surgical Wound
Conditions
Brief 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.
Interventions
Patients who are eligible for enrollment will be treated with Synthetic Electrospun Fiber Matrix immediately after surgical resection to the resulting wound
Sponsors
Acera Surgical, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient is at least 18 years old 2. Patient plans to undergo surgical resection of a cutaneous neoplasm 3. Patient is willing and capable of complying with all protocol requirements 4. Patient or legally authorized representative (LAR) is willing to provide written informed consent prior to participation in study 5. Post-resection surgical wound with a surface area of ≥4 cm2 and ≤ 36cm2
Exclusion criteria
1. Inability to give informed consent or to complete the procedures required for study completion 2. 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 3. Patient is pregnant, breast feeding or planning to become pregnant 4. Patient has a known allergy to resorbable suture materials, e.g. Polyglactin 910 (PGLA), Polydioxanone (PDS) 5. Patients receiving any immunotherapy, radiation, or chemotherapy within the past four weeks prior to resection surgery. 6. Patient has a life expectancy less than six months as assessed by the investigator 7. Patient has an additional non-study related wound within 3 cm of the study wound 8. Study wound is located on the hands or feet 9. Patient has been diagnosed with osteomalacia 10. Resection defect from a squamous cell carcinoma arising from a chronic wound 11. Patient has an uncontrolled thyroid disorder 12. Hgb A1c \> 12% within 3 months prior to enrollment in patients with a known history of diabetes 13. Patient has a BMI \> 34.9 14. Patient has used any tobacco product within the past 30 days prior to surgery 15. Patients with chronic kidney disease on peritoneal or hemodialysis, or with an estimated glomerular filtration rate less than 15mL/min 16. Patients with severe liver disease with active cirrhosis defined as a gross ascites upon clinical exam or a Model for End-stage Liver Disease (MELD)-Na score greater than 15 17. Patient not in reasonable metabolic control in the judgement of the investigator 18. Patient has a known history of poor compliance with medical treatment 19. Patient has a history of radiotherapy to wound bed of interest 20. Patient has been diagnosed with at least one of the following autoimmune connective tissue diseases: lupus, vasculitis, sickle cell, or uncontrolled rheumatoid arthritis 21. Active infection, undrained abscess, or critical colonization of the wound with bacteria in the judgement of the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to wound bed granulation | Weekly assessments until granulation achieved or up to 6 weeks following resection surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to complete wound healing | Until healed or until 16 weeks post resection | 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 | Weekly for up to six weeks post resection | 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 | Weekly for up to 6 weeks post-resection | Time from resection and product place until skin grafting (if patient elects to do so) |
| Skin graft "take" rate | 1 week after skin graft application | Percent of skin graft incorporation as assessed by the investigator, in patients who elect to undergo skin grafting |
| Tissue flap take rate | 1 week after tissue flap procedure | Percent of successful tissue graft incorporation as assessed by the investigator, in patients who elect to undergo tissue flap procedures |
Countries
United States
Contacts
CONTACTMatthew MacEwan, PhD
Outcome results
None listed