Head and Neck CancerPhase 1NCT07856732
Using Silverlon® for Head and Neck Patients With Tracheostomies
A Phase 1 study testing Silverlon® in people with Head and Neck Cancer and Radiation Dermatitis Acute, run by State University of New York - Upstate Medical University at 1 site in United States.
Trial summary
The purpose of this study is to determine if prophylactic silver-nylon burn dressing Silverlon® prevents a severe skin reaction under tracheostomy collars. It also aims to establish whether patients can tolerate Silverlon® under their tracheostomy with daily removal and weekly changes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Radiation Dermatitis Acute, Radiation Treatment
- What is being tested?
- Silverlon®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2026to 30 Jan 2028
- Phase
- Phase 1
- 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
Who may be able to join
- Undergoing definitive head and neck cancer (>4 weeks of treatment)
- Have a tracheostomy
- Age ≥ 18 years
- Must be able to understand and write English
Who cannot join
- Inability to fulfill requirements of the protocol
- Presence of unhealed surgical wounds
- Subjects unable or unwilling to wear Silverlon dressings
- Active infection of treatment area
- Any co-morbidity or condition which, in the opinion of the investigator, may interfere with the assessments and procedures of this protocol.
- Subjects with known sensitivity to silver or nylon.
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
Upstate Medical University
Syracuse, New York, 12310
Karna Sura, MD, 315-464-5276, surak@upstate.edu
About this study
Official title: Feasibility and Tolerability of Silverlon® for Definitive Head and Neck Patients With Tracheostomies
The purpose of this study is to determine if prophylactic silver-nylon burn dressing Silverlon® prevents a severe skin reaction under tracheostomy collars. It also aims to establish whether patients can tolerate Silverlon® under their tracheostomy with daily removal and weekly changes.
- Being tested
- Silverlon®
- 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.
Silverlon®Device
Silverlon® is a specialized, antimicrobial wound dressings that is approved in radiation dermatitis. The study is aimed at determining if this dressing is effective in prophylactically preventing dermatitis in high risk patients.
| Study group | Role | What they receive |
|---|---|---|
| Using Silverlon® | Experimental | Patients will be given Silverlon® Receives: Device: Silverlon® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Silveron dressing
The study will look at median use of the Silveron dressing. Success is defined as > 50% over treatment days (>17/35 days).
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study start30 Aug 2026
- Primary completion30 Aug 2027 (estimated)
- Study completion30 Jan 2028 (estimated)
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 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- State University of New York - Upstate Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Bravida Medical
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07856732
- Sponsor's protocol ID
- IRB2214841
- Status last verified
- Aug 2026
- First submitted
- 20 Aug 2026
- Last updated
- 5 Oct 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 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Tolerability of Silverlon® for Definitive Head and Neck Patients With Tracheostomies
- ClinicalTrials.gov ID
- NCT07856732
- Acronym / sponsor ID
- IRB2214841
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- State University of New York - Upstate Medical UniversityUniversity, hospital or other
- Collaborators
- Bravida Medical
- Study start
- 30 Aug 2026 (actual)
- Primary completion
- 30 Aug 2027 (estimated)
- Study completion
- 30 Jan 2028 (estimated)
- First posted
- 5 Oct 2026 (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 purpose of this study is to determine if prophylactic silver-nylon burn dressing Silverlon® prevents a severe skin reaction under tracheostomy collars. It also aims to establish whether patients can tolerate Silverlon® under their tracheostomy with daily removal and weekly changes.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Using Silverlon® | Experimental | Device: Silverlon®Patients will be given Silverlon® |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Undergoing definitive head and neck cancer (>4 weeks of treatment)
- Have a tracheostomy
- Age ≥ 18 years
- Must be able to understand and write English
Key exclusion criteria (6 listed)
- Inability to fulfill requirements of the protocol
- Presence of unhealed surgical wounds
- Subjects unable or unwilling to wear Silverlon dressings
- Active infection of treatment area
- Any co-morbidity or condition which, in the opinion of the investigator, may interfere with the assessments and procedures of this protocol.
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 |
|---|---|---|
| Silverlon®Silverlon® is a specialized, antimicrobial wound dressings that is approved in radiation dermatitis. The study is aimed at determining if this dressing is effective in prophylactically preventing dermatitis in high risk patients. | Device | Using Silverlon® |
Primary outcome
Feasibility of Silveron dressing
Time frame: 7 weeks
The study will look at median use of the Silveron dressing. Success is defined as > 50% over treatment days (>17/35 days).
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 5 Oct 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Silverlon® in people with Head and Neck Cancer and Radiation Dermatitis Acute, run by State University of New York - Upstate Medical University 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 4 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: looking for participants now, as of the sponsor's last update on 5 Oct 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Karna Sura, MD (315-464-5276, surak@upstate.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Silveron dressing (time frame: 7 weeks). 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 5 Oct 2026.