Observational Study of Restrata for Surgical Wounds
This study is looking at how well a product called Synthetic Electrospun Fiber Matrix (Restrata) helps surgical wounds heal after skin cancers (cutaneous neoplasms) are removed. Researchers want to see how long it takes for the wound bed to form new tissue (granulation) when treated with Restrata. You might be able to join if you are at least 18 years old, are having a skin cancer surgically removed, and are willing to follow the study's instructions. This is an observational study, meaning researchers will watch and record what happens without giving specific treatments beyond the Restrata. The study aims to include 34 participants, but its current status is unclear.
- Study design
- This is an observational study that will include about 34 participants. It is a single-arm study, meaning all participants will receive the same intervention.
- What's involved
- You would receive the Synthetic Electrospun Fiber Matrix (Restrata) on your wound immediately after surgery. Your wound healing will be checked weekly until granulation is achieved or for up to 6 weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your wound healing will be assessed weekly until granulation is achieved or for up to 6 weeks following surgery.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Prospective, Single-arm, Clinical Trial of Electrospun Fiber Matrix (Restrata) in the Treatment of Surgical Defects Secondary to Resection of Malignant Cutaneous Neoplasms
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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What this trial measures
- Time to wound bed granulationWeekly 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.