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

June 17, 2026 updated by: Acera Surgical, Inc.
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
34

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • Recruiting
        • University Nevada - Las Vegas
        • Contact:
        • Principal Investigator:
          • Brian Ward, MD, PhD, FACS

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.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients will be enrolled in a University Hospital Setting

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Time to wound bed granulation
Time Frame: Weekly 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.
Weekly assessments until granulation achieved or up to 6 weeks following resection surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time to complete wound healing
Time Frame: Until healed or until 16 weeks post resection
Total healing time will be documented (in days) at the final follow-up appointment by calculating the difference using the resection visit and "healed" visit dates.
Until healed or until 16 weeks post resection
Patient pain
Time Frame: Weekly for up to six weeks post resection
Pain reported by patient on a Visual Analogue Scale (VAS), with 0 indicating no pain and 10 indicating worst pain possible. Lower scores are indicative of a better outcome
Weekly for up to six weeks post resection
Time to skin grafting
Time Frame: Weekly for up to 6 weeks post-resection
Time from resection and product place until skin grafting (if patient elects to do so)
Weekly for up to 6 weeks post-resection
Skin graft "take" rate
Time Frame: 1 week after skin graft application
Percent of skin graft incorporation as assessed by the investigator, in patients who elect to undergo skin grafting
1 week after skin graft application
Tissue flap take rate
Time Frame: 1 week after tissue flap procedure
Percent of successful tissue graft incorporation as assessed by the investigator, in patients who elect to undergo tissue flap procedures
1 week after tissue flap procedure

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Scar quality
Time Frame: At the time of complete wound closure and at the 6 month post-resection follow up
Scar quality using a Vancouver Scar Scale (VSS). The scale ranges from 0 (normal skin) to 13 (worst scar outcome). Lower scores are indicative of a better scar outcome
At the time of complete wound closure and at the 6 month post-resection follow up
Infection rate and severity
Time Frame: to be assessed at each visit for up to 6 months post resection
Incidence and severity of wound bed infection (if one occurs) per CTCAE V5.0 definitions ranging from 1 (localized, local intervention indicated) to 5 (death). Lower scores are indicative of milder infections
to be assessed at each visit for up to 6 months post resection
Skin Graft Failure
Time Frame: To be assessed at each post skin graft visit for up to 6 months post-resection
Incidence of inadequate skin graft adherence to the underlying wound bed as assessed by the investigator in patients who have received a skin graft
To be assessed at each post skin graft visit for up to 6 months post-resection
Tissue flap failure
Time Frame: Each post-flap follow up visit for up to 6 months post-resection
Incidence of complete flap necrosis or need for total flap removal in patients who receive a tissue flap
Each post-flap follow up visit for up to 6 months post-resection
Incidence of local skin cancer recurrence
Time Frame: at the 6 month post-resection follow up
local recurrence of skin cancer
at the 6 month post-resection follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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 Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 31, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 26, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 28, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 29, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 24-RES-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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