Effectiveness of KeraStat Gel for Improved Cosmesis of Partial Thickness Burns

KeraNetics

Status: Terminated

Conditions: Partial-thickness Burn

Treatments: Device: KeraStat Gel; Device: Silver Sulfadiazine

Study type: Interventional

Funder types: Other; Industry; Other U.S. Federal agency

Identifiers

NCT03564795

KSGL-CRD-003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 14 patients

Sex: All

Ages: 6 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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14 participants in 2 patient groups

KeraStat Gel

Experimental group

Description:

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).

Treatment:

Device: KeraStat Gel

Silver Sulfadiazine

Active Comparator group

Description:

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.

Treatment:

Device: Silver Sulfadiazine