Clinical trial NCT06578650: A Prospective, Single-arm, Clinical Trial of Electrospun Fiber Matrix (Restrata) in the Treatment of Surgical Defects Secondary to Resection of Malignant Cutaneous Neoplasms
Official title: A Prospective, Single-arm, Clinical Trial of Electrospun Fiber Matrix (Restrata) in the Treatment of Surgical Defects Secondary to Resection of Malignant Cutaneous Neoplasms
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Surgical Wound
Lead sponsor: Acera Surgical, Inc.
Sponsor class: INDUSTRY
First posted: 2024-08-29
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be enrolled in a University Hospital Setting

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.


Eligibility criteria: 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

Primary outcomes:
measure: Time to wound bed granulation
timeFrame: Weekly assessments until granulation achieved or up to 6 weeks following resection surgery
Secondary outcomes:
measure: Time to complete wound healing
timeFrame: Until healed or until 16 weeks post resection
measure: Patient pain
timeFrame: Weekly for up to six weeks post resection
measure: Time to skin grafting
timeFrame: Weekly for up to 6 weeks post-resection
measure: Skin graft "take" rate
timeFrame: 1 week after skin graft application
measure: Tissue flap take rate
timeFrame: 1 week after tissue flap procedure
Other outcomes:
measure: Scar quality
timeFrame: At the time of complete wound closure and at the 6 month post-resection follow up
measure: Infection rate and severity
timeFrame: to be assessed at each visit for up to 6 months post resection
measure: Skin Graft Failure
timeFrame: To be assessed at each post skin graft visit for up to 6 months post-resection
measure: Tissue flap failure
timeFrame: Each post-flap follow up visit for up to 6 months post-resection
measure: Incidence of local skin cancer recurrence
timeFrame: at the 6 month post-resection follow up
Locations:
city: Las Vegas
country: United States
facility: University Nevada - Las Vegas
state: Nevada
Study officials:
References: