Wound HealNCT04829331
Utility of Restrata With Split Thickness Skin Graft to Reconstruct the Forearm Donor Site
A study testing Restrata in people with Wound Heal, run by Acera Surgical, Inc. at 1 site in United States.
Trial summary
Understand association between use of Restrata (Acera Surgical Inc., St. Louis, MO) in forearm flap reconstruction with donor site healing and function Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Wound Heal
- What is being tested?
- Restrata
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Apr 2021to 1 Jan 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients age 19 or greater that will undergo radial forearm free flap or ulnar free flap.
- Photo documentation of wound bed at two weeks and four weeks must be obtainable either by physician or patient.
Who cannot join
- Active systemic immunosuppression (active use of high-dose steroids (≥40mg prednisone daily or equivalent) or other immunosuppressive medications OR medical conditions causing immunosuppression, i.e. human immunodeficiency virus etc).
- Diabetes mellitus with most recent Hemoglobin A1c ≥10.0 within 30 days prior to surgery.
- Morbid obesity (BMI >40).
- Inability to maintain wrist immobilization for full planned period.
- Severe malnutrition (prealbumin levels <10 mg per dL within 30 days prior to surgery OR BMI <15 (very severely underweight).
- Other conditions felt to significantly impair wound healing per surgeon discretion.
Trial locations and contacts
1 site in 1 country.
About this study
Understand association between use of Restrata (Acera Surgical Inc., St. Louis, MO) in forearm flap reconstruction with donor site healing and function
- Conditions
- Wound Heal
- Being tested
- Restrata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RestrataDevice
Restrata is a sterile, single use device intended for use in local management of wounds
| Study group | Role | What they receive |
|---|---|---|
| Restrata with a split-thickness skin graft | Experimental | Not described Receives: Device: Restrata |
| Split-thickness skin graft alone | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tendon Exposure
Percentage of participants with tendon exposure
Measured: 4 weeks post-operatively
Surface Area of Split-thickness Skin Graft Incorporation
Percentage of surface area of split-thickness skin graft incorporation
Measured: 4 weeks post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2021
- Study start9 Apr 2021
- Primary completion1 Jan 2022
- Study completion1 Jan 2022
Why it stopped: Lack of clinical research staff
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Wound HealStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acera Surgical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04829331
- Sponsor's protocol ID
- 21-RES-003
- Status last verified
- Mar 2023
- First submitted
- 31 Mar 2021
- Last updated
- 18 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of Restrata With Split Thickness Skin Graft to Reconstruct the Forearm Donor Site
- ClinicalTrials.gov ID
- NCT04829331
- Acronym / sponsor ID
- 21-RES-003
- Conditions
- Wound Heal
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of clinical research staff
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Acera Surgical, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Apr 2021 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 2 Apr 2021 (actual)
- Results
- Posted 18 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Understand association between use of Restrata (Acera Surgical Inc., St. Louis, MO) in forearm flap reconstruction with donor site healing and function
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Restrata with a split-thickness skin graft | Experimental | Device: Restrata |
| Split-thickness skin graft alone | No intervention | – |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All patients age 19 or greater that will undergo radial forearm free flap or ulnar free flap.
- Photo documentation of wound bed at two weeks and four weeks must be obtainable either by physician or patient.
Key exclusion criteria (6 listed)
- Active systemic immunosuppression (active use of high-dose steroids (≥40mg prednisone daily or equivalent) or other immunosuppressive medications OR medical conditions causing immunosuppression, i.e. human immunodeficiency virus etc).
- Diabetes mellitus with most recent Hemoglobin A1c ≥10.0 within 30 days prior to surgery.
- Morbid obesity (BMI >40).
- Inability to maintain wrist immobilization for full planned period.
- Severe malnutrition (prealbumin levels <10 mg per dL within 30 days prior to surgery OR BMI <15 (very severely underweight).
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 |
|---|---|---|
| RestrataRestrata is a sterile, single use device intended for use in local management of wounds | Device | Restrata with a split-thickness skin graft |
Primary outcome
Tendon Exposure
Time frame: 4 weeks post-operatively
Percentage of participants with tendon exposure
Surface Area of Split-thickness Skin Graft Incorporation
Time frame: 4 weeks post-operatively
Percentage of surface area of split-thickness skin graft incorporation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Restrata in people with Wound Heal, 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 2 inclusion and 6 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: stopped early, as of the sponsor's last update on 18 Apr 2023. 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?
Yes. Results are posted in the registry (first posted 18 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tendon Exposure (time frame: 4 weeks post-operatively). The study lists 2 primary outcomes in all. 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 Apr 2023.