Burn Wounds - Partial Thickness (2nd Degree)NCT07337616
Field Shield Wound Dressing Study
A study testing Field Shield Wound Dressing and Silverlon in people with Burn Wounds - Partial Thickness (2nd Degree), run by KeriCure Medical at 2 sites in United States.
Trial summary
This study is to compare the Field Shield Wound Dressing (FSWD) as a treatment for burn wounds to a standard of care burn wound dressing to evaluate healing, infection, pain/discomfort, and deepening of wound over time. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Burn Wounds - Partial Thickness (2nd Degree)
- What is being tested?
- Field Shield Wound Dressing and Silverlon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 May 2025to 29 Sep 2026
- Phase
- Interventional
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Thermal injury size 5-30% TBSA
- Admitted to the burn center and enroll able within 72 hours of injury
- Subject has two distinct areas of 100cm2 or larger of intermediate to deep partial thickness burns (study sites). These areas are judged to be comparable in depth.
- The subject and or caregiver is able and willing to follow the protocol requirements
- Achieve wound photos and dressing change at 3 days
Who cannot join
- Subject has congestive heart failure, oxygen-dependent chronic lung disease, end-stage renal disease, or liver cirrhosis
- Subject is undergoing hospice care.
- Subject is currently being treated for an active malignant disease
- Subject has other concurrent conditions that in the opinion of the Investigator may compromise subject safety
- Known contraindications to silver metals, silver chloride, or silver tetraoxide
- Known contraindications to lidocaine
Show all 15Show fewer
- Known allergies to any components of either primary dressing in the study
- Known allergies to the silicone or adhesives in secondary dressings
- Burns located on the hands, feet, face, and/or genitals will be excluded from treatment sites, but will be included in the total TBSA calculation
- Subject has a combined TBSA of 31% or greater of partial and/or full thickness burn wounds
- Concurrent participation in another clinical trial that involves an investigational drug or device that would interfere with this study.
- Subject is pregnant, breast feeding, or planning to become pregnant.
- Subjects who, within 60 days prior to enrollment, have a history of more than two weeks treatment with immunosuppressants (including systemic corticosteroids >10mg daily dose), cytotoxic chemotherapy, application of topical steroids within one month prior to enrollment, or who receive such medications during the screening period, or who are anticipated to require such medications during the course of the study.
- Burn study site(s) has been previously treated with tissue engineered materials (e.g., Apligraf® or Dermagraft®) or other scaffold materials (e.g., Oasis, Matristem) preceding the study wound dressing application.
- Burn study site(s) has been previously treated with a silvadene
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Pam Sovine contact
United States2 sites, 1 recruiting
- Recruiting
Valleywise Health
Phoenix, Arizona, 82008
Natalie Kesler, BSN, 602-344-5726, natalie.kesler@valleywisehealth.org
Kevin Foster, MD
- Active, not recruiting
United State Army Institute of Surgical Research
San Antonio, Texas, 78234
About this study
Official title: Clinical Assessment of Field Shield Wound Dressing of Large Surface Area Burn Wounds
This study is to compare the Field Shield Wound Dressing (FSWD) as a treatment for burn wounds to a standard of care burn wound dressing to evaluate healing, infection, pain/discomfort, and deepening of wound over time.
Read the detailed description
To assess FSWD in comparison to standard of care dressing, subjects will undergo dressing changes and visual assessments.
- Being tested
- Field Shield Wound Dressing, Silverlon
- Keywords
- FSWD, Burn wounds
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Field Shield Wound DressingDevice
Spray on wound dressing.
SilverlonDevice
Silver dressing
| Study group | Role | What they receive |
|---|---|---|
| FSWD wound site | Experimental | One burn wound site on each participant will receive study treatment. Receives: Device: Field Shield Wound Dressing |
| Control treatment | Active comparator | One burn wound site on each patient receives standard treatment with silver dressing. Receives: Device: Silverlon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound closure
Wound closure will be assessed at each time point (day 3, 7, 12, 19, 28, 35). The probability of wound closure will be assessed with a cluster randomized Generalized Estimating Equations (GEE) model of the probability of closure in terms of treatment and clinical site with clustering by patient and login link.
Measured: From enrollment to end of study, 4-6 months.
Secondary outcomes (6)
Infection
Rate of occurrence of infection per uint time.
Measured: 35 days
Surgical debridement
Rate of occurrence of surgical debridement and rate of occurrence of grafting
Measured: 35 days
Pain severity
Pain will measured using a visual analog scale (0-10) at each dressing change comparing each site pain ratings.
Measured: days 3, 7, 12, 19, and 28.
Scar
The Patient and Observer Scar Assessment Scale will be conducted to evaluate scars, comparing the two sites at two time points.
Measured: day 35 and 4-6 months
Health-related quality of life
A burn specific health-related quality of life assessment will be conducted and compared at two time points.
Measured: day 35 and 4-6 months
Function
The Patient Specific Function Scale assessment will be conducted and compared at three time points
Measured: Day 3, 35 and 4-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start1 May 2025
- Primary completion30 Jul 2026 (estimated)
- Study completion29 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burn Wounds - Partial Thickness (2nd Degree)Studies 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
- Model description
- In this study each subject will serve as their own control receiving the intervention dressing on one wound and the standard of care dressing on another wound.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KeriCure Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Valleywise Health, United States Army Institute of Surgical Research, The University of Texas Health Science Center at San Antonio
- Responsible party
- Sponsor
- Investigators
- Kerriann Greenhalgh, PH.D., Principal investigator, KeriCure Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07337616
- Sponsor's protocol ID
- 20240572
- Status last verified
- Jan 2026
- First submitted
- 8 Jan 2026
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: All collected de-identified IPD that underlie results in a publication.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Assessment of Field Shield Wound Dressing of Large Surface Area Burn Wounds
- ClinicalTrials.gov ID
- NCT07337616
- Acronym / sponsor ID
- 20240572
- Keywords
- FSWD, Burn wounds
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- KeriCure MedicalIndustry (pharma, biotech, devices)
- Collaborators
- Valleywise Health, United States Army Institute of Surgical Research, The University of Texas Health Science Center at San Antonio
- Study start
- 1 May 2025 (actual)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 29 Sep 2026 (estimated)
- First posted
- 13 Jan 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.
This study is to compare the Field Shield Wound Dressing (FSWD) as a treatment for burn wounds to a standard of care burn wound dressing to evaluate healing, infection, pain/discomfort, and deepening of wound over time.
Detailed description
To assess FSWD in comparison to standard of care dressing, subjects will undergo dressing changes and visual assessments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- In this study each subject will serve as their own control receiving the intervention dressing on one wound and the standard of care dressing on another wound.
| Arm | Type | Receives |
|---|---|---|
| FSWD wound site | Experimental | Device: Field Shield Wound DressingOne burn wound site on each participant will receive study treatment. |
| Control treatment | Active comparator | Device: SilverlonOne burn wound site on each patient receives standard treatment with silver dressing. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Thermal injury size 5-30% TBSA
- Admitted to the burn center and enroll able within 72 hours of injury
- Subject has two distinct areas of 100cm2 or larger of intermediate to deep partial thickness burns (study sites). These areas are judged to be comparable in depth.
- The subject and or caregiver is able and willing to follow the protocol requirements
- Achieve wound photos and dressing change at 3 days
Key exclusion criteria (15 listed)
- Subject has congestive heart failure, oxygen-dependent chronic lung disease, end-stage renal disease, or liver cirrhosis
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 |
|---|---|---|
| Field Shield Wound DressingSpray on wound dressing. | Device | FSWD wound site |
| SilverlonSilver dressing | Device | Control treatment |
Primary outcome
Wound closure
Time frame: From enrollment to end of study, 4-6 months.
Wound closure will be assessed at each time point (day 3, 7, 12, 19, 28, 35). The probability of wound closure will be assessed with a cluster randomized Generalized Estimating Equations (GEE) model of the probability of closure in terms of treatment and clinical site with clustering by patient and login link.
6 secondary outcomes
Infection
Time frame: 35 days
Surgical debridement
Time frame: 35 days
Pain severity
Time frame: days 3, 7, 12, 19, and 28.
Scar
Time frame: day 35 and 4-6 months
Health-related quality of life
Time frame: day 35 and 4-6 months
Function
Time frame: Day 3, 35 and 4-6 months
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 13 Jan 2026.
- Individual participant dataSharing planned: Yes. All collected de-identified IPD that underlie results in a publication.
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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.
Pam Sovine contact
Kerriann Greenhalgh, PH.D. principal investigator
KeriCure Medical
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Field Shield Wound Dressing and Silverlon in people with Burn Wounds - Partial Thickness (2nd Degree), run by KeriCure Medical at 2 sites 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 15 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 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Kerriann Greenhalgh, Ph.D. (813-391-7722, kgreenha@kericure.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound closure (time frame: From enrollment to end of study, 4-6 months.). 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 Jan 2026.