RECRUITING

A Prospective, Single-arm, Clinical Trial of Electrospun Fiber Matrix (Restrata) in the Treatment of Surgical Defects Secondary to Resection of Malignant Cutaneous Neoplasms

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2024-10-31

Study Completion:2025-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06578650

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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

Inclusion Criteria

Exclusion 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

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

Contacts and Locations

Study Contact

Matthew MacEwan, PhD

CONTACT

440-477-1890

macewan@acera-surgical.com

Study Locations (Sites)

University Nevada - Las Vegas

Las Vegas, Nevada, 89102

United States

Collaborators and Investigators

Sponsor: Acera Surgical, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-31

Study Completion Date2025-08

Study Record Updates

Study Start Date2024-10-31

Study Completion Date2025-08

Terms related to this study

Additional Relevant MeSH Terms

Surgical Wound