Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:02 PM
Ignite Modification Date:
2025-12-24 @ 5:02 PM
NCT ID:
NCT06578650
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06578650
Study Brief:
Protocol Section:
NCT06578650