Surgical WoundNCT06578650
A Prospective, Single-arm, Clinical Trial of Electrospun Fiber Matrix (Restrata) in the Treatment of Surgical Defects Secondary to Resection of Malignant Cutaneous Neoplasms
An observational study of Surgical Wound, run by Acera Surgical, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Wound
- What is being tested?
- Synthetic Electrospun Fiber Matrix
- Type of treatment
- Medical device
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Oct 2024to Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be enrolled in a University Hospital Setting
Who may be able to join
- 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
Who cannot join
- 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)
- 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
Show all 21Show fewer
- Patient has an additional non-study related wound within 3 cm of the study wound
- Study wound is located on the hands or feet
- Patient has been diagnosed with osteomalacia
- Resection defect from a squamous cell carcinoma arising from a chronic wound
- Patient has an uncontrolled thyroid disorder
- Hgb A1c > 12% within 3 months prior to enrollment in patients with a known history of diabetes
- Patient has a BMI > 34.9
- Patient has used any tobacco product within the past 30 days prior to surgery
- Patients with chronic kidney disease on peritoneal or hemodialysis, or with an estimated glomerular filtration rate less than 15mL/min
- 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
- Patient not in reasonable metabolic control in the judgement of the investigator
- Patient has a known history of poor compliance with medical treatment
- Patient has a history of radiotherapy to wound bed of interest
- Patient has been diagnosed with at least one of the following autoimmune connective tissue diseases: lupus, vasculitis, sickle cell, or uncontrolled rheumatoid arthritis
- Active infection, undrained abscess, or critical colonization of the wound with bacteria in the judgement of the investigator
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University Nevada - Las Vegas
Las Vegas, Nevada, 89102
Michelle Tomasino, CHPSE, 702-895-4923, michelle.tomasino@unlv.edu
Brian Ward, MD, PhD, FACS
About this study
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.
- Conditions
- Surgical Wound
- Being tested
- Synthetic Electrospun Fiber Matrix
- Medical subject headings
- Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Synthetic Electrospun Fiber MatrixDevice
Patients who are eligible for enrollment will be treated with Synthetic Electrospun Fiber Matrix immediately after surgical resection to the resulting wound
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to wound bed granulation
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.
Measured: Weekly assessments until granulation achieved or up to 6 weeks following resection surgery
Secondary outcomes (5)
Time to complete wound healing
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.
Measured: Until healed or until 16 weeks post resection
Patient pain
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
Measured: Weekly for up to six weeks post resection
Time to skin grafting
Time from resection and product place until skin grafting (if patient elects to do so)
Measured: Weekly for up to 6 weeks post-resection
Skin graft "take" rate
Percent of skin graft incorporation as assessed by the investigator, in patients who elect to undergo skin grafting
Measured: 1 week after skin graft application
Tissue flap take rate
Percent of successful tissue graft incorporation as assessed by the investigator, in patients who elect to undergo tissue flap procedures
Measured: 1 week after tissue flap procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2024
- Study start31 Oct 2024
- Primary completionAug 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical WoundStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Acera Surgical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06578650
- Sponsor's protocol ID
- 24-RES-002
- Status last verified
- Jun 2026
- First submitted
- 26 Aug 2024
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06578650
- Acronym / sponsor ID
- 24-RES-002
- Conditions
- Surgical Wound
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Acera Surgical, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Oct 2024 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 29 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be enrolled in a University Hospital Setting
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (21 listed)
- 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)
- Patients receiving any immunotherapy, radiation, or chemotherapy within the past four weeks prior to resection surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Synthetic Electrospun Fiber MatrixPatients who are eligible for enrollment will be treated with Synthetic Electrospun Fiber Matrix immediately after surgical resection to the resulting wound | Device | – |
Primary outcome
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.
5 secondary outcomes
Time to complete wound healing
Time frame: Until healed or until 16 weeks post resection
Patient pain
Time frame: Weekly for up to six weeks post resection
Time to skin grafting
Time frame: Weekly for up to 6 weeks post-resection
Skin graft "take" rate
Time frame: 1 week after skin graft application
Tissue flap take rate
Time frame: 1 week after tissue flap procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Surgical Wound
Not yet recruiting
Safety Study of Microlyte DualGuard
Wound Closure, Wound Care
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
Recruiting
SIRI Levels Following PENG Block in Pediatric Hip Surgery
Hip Dysplasia
RecruitingPhase 4
PENG With LFCB vs. ESP Blocks for Pediatric Hip Surgery
Hip Disease, Hip Dysplasia
Not yet recruiting
Biodegradable Magnesium Screws for Unstable Ankle Fracture Surgery
Ankle Fractures, Syndesmotic Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgical Wound, run by Acera Surgical, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matthew MacEwan, PhD (440-477-1890, macewan@acera-surgical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to wound bed granulation (time frame: Weekly assessments until granulation achieved or up to 6 weeks following resection surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.