Effectiveness of KeraStat Gel for Improved Cosmesis of Partial Thickness Burns

Not Applicable

Terminated

Brief Summary: 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: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
KeraStat Gel	KeraStat Gel	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).
Silver Sulfadiazine	Silver Sulfadiazine	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.

Primary Outcome Measures

Name	Time	Method
Improved Cosmesis	One year post burn	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.

Secondary Outcome Measures

Name	Time	Method
Pain During Dressing Change	Period during first month when dressing changes are required (Day 0, Day 7, Day 14, Day 21, Day 28).	Subject will complete Visual Analog Pain Scale (VAS) before and after in-clinic dressing changes. The Visual Analog Scale is presented as a 10 cm horizontal line ranging from 'No Pain' (0 cm) to 'Worst Pain Imaginable' (10 cm). The patient will mark the line to represent his or her level of pain before and after dressing changes.