Effectiveness of KeraStat Gel for Improved Cosmesis of Partial Thickness Burns

Study Overview
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Brief Summary
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A randomized, controlled, 30-subject, within-subject trial for examining the effectiveness of KeraStat Gel, as opposed to the institutional standard of care, silver sulfadiazine, in improving cosmesis of the healed wound.

Detailed Description
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The study seeks to determine whether the use of KeraStat Gel as the primary dressing for partial thickness burns results in improved cosmesis of the healed wound, and results in less painful dressing changes, faster reepithelialization, and reduction in need for excision and grafting. The study will enroll 30 subjects. The study design is a randomized, controlled, within-subject trial to compare the effectiveness of KeraStat Gel vs. standard of care (SOC), silver sulfadiazine (SSD). Each of two distinct burns will be randomized to the use of KeraStat Gel or SOC. Patients will be seen weekly for the first month and then at months 3, 6, and 12 post burn.

Official Title
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Effectiveness of KeraStat Gel for Improved Cosmesis of Partial Thickness Burns

Conditions
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Partial-thickness Burn

Intervention / Treatment
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* Device: KeraStat Gel
* Device: Silver Sulfadiazine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Presenting with at least two comparable, discrete, and separate partial thickness thermal burns, as determined by the Investigator, measuring 50 - 1,000 cm2 each Study wounds identified are partial thickness depth KeraStat Gel and SSD can be applied to randomized study burn wounds as definitive care treatment within 24 hours from time of injury] Overall total body surface area burned < 20% Exclusion Criteria: Pregnant or nursing Prisoner Presence of inhalation injury, as determined by the Investigator Injury requiring formal intravenous fluid resuscitation Concomitant non-thermal traumatic injuries Chronic medical conditions including, but not limited to, documented renal impairment (Cr > 2.5 mg/dL), hepatic impairment (Total bilirubin > 2.5 mg/dL), thromboembolic disorders, active infection in study wound areas, uncontrolled diabetes (HbA1C > 7%), HIV infection, history of melanoma or systemic malignancy within the last 10 years Receiving corticosteroids, immunosuppressive agents, radiation or chemotherapy, topical growth factors, or any other medication the Investigator feels will affect wound healing Not expected to live at least 13 months post-burn Received an investigational drug or biologic within 3 months prior to injury Previously treated with a skin graft at either of the treatment sites Chemical or electrical burn Known or documented allergy to sulfonamides Proposed study wounds are full thickness Any condition the Investigator determines will compromise subject safety or prevent the subject from completing the study

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, controlled within-subject trial of 30 patients, each of whom will have a minimum of one burn treated with the KeraStat Gel device and one burn treated with the standard of care dressing
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: KeraStat Gel<br>Each enrolled subject will have at least one eligible burn randomized to the KeraStat Gel arm. This burn will be dressed with KeraStat Gel and covered by a secondary dressing. Subjects will be instructed to change the dressing and re-apply the KeraStat Gel per the instructions for use (at least every 3 days). | Device: KeraStat Gel<br>* Wound dressing for partial thickness burns<br>|
| Active Comparator: Silver Sulfadiazine<br>Each enrolled subject will have at least one eligible burn randomized to the Silver Sulfadiazine arm. This burn will be dressed with the Silver Sulfadiazine and covered by a secondary dressing. Subjects will be instructed to change the dressing and re-apply the Silver Sulfadiazine per the institution's Standard of Care instructions. | Device: Silver Sulfadiazine<br>* Wound dressing for partial thickness burns<br>* Other names: SSD;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improved Cosmesis | The degree of cosmetic improvement of the healed wound will be assessed by Patient and Observer Scar Assessment Scale (POSAS) at one year. This scale consists of two parts: a Patient Scale and an Observer Scale. Both scales contain six items that are scored numerically on a 10-point range, where a '10' indicates the 'worst possible' [e.g. itching or pigmentation] and a '1' indicates normal skin. The Patient Scale is summed to make a 'Total Patient Score ranging from 6 - 60. The Observer Scale is summed to make up a 'Total Observer Score' ranging from 6 - 60. The Total Patient Score and Total Observer Score can be summed into a Total POSAS Score ranging from 12 to 120. | One year post burn | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain during Dressing Change | Subject will complete Visual Analog Pain Scale (VAS) before and after in-clinic dressing changes. The Visual Analog Scale is presented as a 100 mm horizontal line ranging from 'No Pain' (0 mm) to 'Worst Pain Imaginable' (100 mm). The patient will mark the line to represent his or her level of pain before and after dressing changes. | Period during first month when dressing changes are required | 
| Time to Reepithelialization | Digital Images will be taken weekly over the first month in order to assess % reepithelialization | First Month | 
| Need for Excision and Grafting | The need for excision and/or grafting will be documented for each treated burn for each subject | Entire study (one year) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Wound Dressing, Keratin, Hydrogel, Burn Dressing