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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAcera Surgical, Inc.

About this trial

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

Qualifiers

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

Disqualifiers

Inability to give informed consent or to complete the procedures required for study completion

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)

Trial design

Treatments tested in this trial

  • Synthetic Electrospun Fiber Matrix

Treatment groups

No treatment groups listed

Sponsors and collaborators