Field Shield Wound Dressing Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-01

Study Completion Date

2026-09-29

Brief Summary

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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.

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Detailed Description

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To assess FSWD in comparison to standard of care dressing, subjects will undergo dressing changes and visual assessments.

Conditions

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Burn Wounds - Partial Thickness (2nd Degree)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Only the individual performing dressing changes will know which dressing is applied to which site. All others will be blinded.

Study Groups

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FSWD wound site

One burn wound site on each participant will receive study treatment.

Group Type EXPERIMENTAL

Field Shield Wound Dressing

Intervention Type DEVICE

Spray on wound dressing.

Control treatment

One burn wound site on each patient receives standard treatment with silver dressing.

Group Type ACTIVE_COMPARATOR

Silverlon

Intervention Type DEVICE

Silver dressing

Interventions

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Field Shield Wound Dressing

Spray on wound dressing.

Intervention Type DEVICE

Silverlon

Silver dressing

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No