A Prospective, Single-arm, Clinical Trial of Electrospun Fiber Matrix (Restrata) in the Treatment… (NCT06578650) | Clinical Trial Compass
RecruitingNot Applicable
A Prospective, Single-arm, Clinical Trial of Electrospun Fiber Matrix (Restrata) in the Treatment of Surgical Defects Secondary to Resection of Malignant Cutaneous Neoplasms
United States34 participantsStarted 2024-10-31
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patient is at least 18 years old
. Patient plans to undergo surgical resection of a cutaneous neoplasm
. Patient is willing and capable of complying with all protocol requirements
. Patient or legally authorized representative (LAR) is willing to provide written informed consent prior to participation in study
. Post-resection surgical wound with a surface area of ≥4 cm2 and ≤ 36cm2
Exclusion criteria
. Inability to give informed consent or to complete the procedures required for study completion
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Time to wound bed granulation
Timeframe: Weekly assessments until granulation achieved or up to 6 weeks following resection surgery
. 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
. Patient is pregnant, breast feeding or planning to become pregnant
. Patient has a known allergy to resorbable suture materials, e.g. Polyglactin 910 (PGLA), Polydioxanone (PDS)
. Patients receiving any immunotherapy, radiation, or chemotherapy within the past four weeks prior to resection surgery.
. Patient has a life expectancy less than six months as assessed by the investigator
. Patient has an additional non-study related wound within 3 cm of the study wound