Head and Neck CancerPhase 2NCT04880603
Utility of Restrata With Split-thickness Skin Graft to Reconstruct the Forearm Donor Site
A Phase 2 study testing Restrata Graft in people with Head and Neck Cancer, run by Nebraska Methodist Health System at 1 site in United States.
Trial summary
Adult patients undergoing a radial forearm free flap or ulnar forearm free flap will be randomized to the use of the Restrata graft in combination with split-thickness skin graft for reconstruction. Photos will document whether the Restata graft aids in the healing. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Restrata Graft
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Apr 2021to 25 Apr 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
Adult patients undergoing a radial forearm free flap or ulnar forearm free flap will be randomized to the use of the Restrata graft in combination with split-thickness skin graft for reconstruction. Photos will document whether the Restata graft aids in the healing.
- Conditions
- Head and Neck Cancer
- Being tested
- Restrata Graft, Standard of Care Skin Graft
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Restrata GraftDevice
Restrata will be meshed in a 1:2 fashion to allow for egress of serous fluid and minimize risk of fluid collection. Restrata will be applied to the entire wound bed not amenable to primary closure and will be underlaid beneath the surrounding skin edges. A split-thickness skin graft is harvested from patient's thigh at 15:1000 inches and placed on top of the Restrata to cover the entire wound bed. The graft is sutured in place using suture choice of surgeon's preference.
Standard of Care Skin GraftProcedure or surgery
Standard of Care Skin Graft
| Study group | Role | What they receive |
|---|---|---|
| A - Standard of Care | Active comparator | Not described Receives: Procedure: Standard of Care Skin Graft |
| B - Restrata Graft | Experimental | Not described Receives: Device: Restrata Graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tendon exposure
Tendon exposure at four weeks post-operatively (Yes/No).
Measured: 4 weeks post-operation
Percentage of surface area
Percentage of surface area of split-thickness skin graft incorporation at four weeks postoperatively.
Measured: 4 weeks post operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2021
- Study start5 Apr 2021
- Primary completion25 Apr 2022
- Study completion25 Apr 2022
Why it stopped: Investigators no longer interested in pursuing
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nebraska Methodist Health System
- Sponsor type
- University, hospital or other
- Collaborators
- Acera Surgical, Inc.
- Responsible party
- Sponsor
- Investigators
- Robert Lindau, MD, Principal investigator, Nebraska Methodist Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04880603
- Sponsor's protocol ID
- Restrata
- Status last verified
- May 2022
- First submitted
- 5 May 2021
- Last updated
- 13 May 2022
- Results posted
- 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 13 May 2022. 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
- NCT04880603
- Acronym / sponsor ID
- Restrata
- Conditions
- Head and Neck Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Investigators no longer interested in pursuing
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Nebraska Methodist Health SystemUniversity, hospital or other
- Collaborators
- Acera Surgical, Inc.
- Study start
- 5 Apr 2021 (actual)
- Primary completion
- 25 Apr 2022 (actual)
- Study completion
- 25 Apr 2022 (actual)
- First posted
- 11 May 2021 (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.
Adult patients undergoing a radial forearm free flap or ulnar forearm free flap will be randomized to the use of the Restrata graft in combination with split-thickness skin graft for reconstruction. Photos will document whether the Restata graft aids in the healing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A - Standard of Care | Active comparator | Procedure: Standard of Care Skin Graft |
| B - Restrata Graft | Experimental | Device: Restrata Graft |
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 |
|---|---|---|
| Restrata GraftRestrata will be meshed in a 1:2 fashion to allow for egress of serous fluid and minimize risk of fluid collection. Restrata will be applied to the entire wound bed not amenable to primary closure and will be underlaid beneath the surrounding skin edges. A split-thickness skin graft is harvested from patient's thigh at 15:1000 inches and placed on top of the Restrata to cover the entire wound bed. The graft is sutured in place using suture choice of surgeon's preference. | Device | B - Restrata Graft |
| Standard of Care Skin GraftStandard of Care Skin Graft | Procedure or surgery | A - Standard of Care |
Primary outcome
Tendon exposure
Time frame: 4 weeks post-operation
Tendon exposure at four weeks post-operatively (Yes/No).
Percentage of surface area
Time frame: 4 weeks post operation
Percentage of surface area of split-thickness skin graft incorporation at four weeks postoperatively.
Results and safety
The study was stopped early (reason given: Investigators no longer interested in pursuing). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2022.
- Individual participant dataSharing planned: No
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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.
Robert Lindau, MD principal investigator
Nebraska Methodist Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Restrata Graft in people with Head and Neck Cancer, run by Nebraska Methodist Health System 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 13 May 2022. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Investigators no longer interested in pursuing). Results are not available in the source record.
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-operation). 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 13 May 2022.