Clinical trial NCT03564795: Effectiveness of KeraStat Gel for Improved Cosmesis of Partial Thickness Burns
Official title: Effectiveness of KeraStat Gel for Improved Cosmesis of Partial Thickness Burns
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Partial-thickness Burn
Keywords: Wound Dressing
Keratin
Hydrogel
Burn Dressing
Lead sponsor: KeraNetics, LLC
Sponsor class: INDUSTRY
Collaborators: name: Wake Forest University
name: United States Department of Defense
First posted: 2018-06-21
Enrollment: 14
Sex: ALL
Minimum age (years): 6
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Improved Cosmesis
timeFrame: One year post burn
Secondary outcomes:
measure: Pain During Dressing Change
timeFrame: Period during first month when dressing changes are required (Day 0, Day 7, Day 14, Day 21, Day 28).
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest Burn Center
name: James H Holmes IV, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wasiak J, Cleland H, Campbell F. Dressings for superficial and partial thickness burns. Cochrane Database Syst Rev. 2008 Oct 8;(4):CD002106. doi: 10.1002/14651858.CD002106.pub3.
citation: Tandara AA, Mustoe TA. The role of the epidermis in the control of scarring: evidence for mechanism of action for silicone gel. J Plast Reconstr Aesthet Surg. 2008 Oct;61(10):1219-25. doi: 10.1016/j.bjps.2008.03.022. Epub 2008 Jul 23.
citation: Mustoe TA, Gurjala A. The role of the epidermis and the mechanism of action of occlusive dressings in scarring. Wound Repair Regen. 2011 Sep;19 Suppl 1(0 1):s16-21. doi: 10.1111/j.1524-475X.2011.00709.x.
citation: Steinstraesser L, Flak E, Witte B, Ring A, Tilkorn D, Hauser J, Langer S, Steinau HU, Al-Benna S. Pressure garment therapy alone and in combination with silicone for the prevention of hypertrophic scarring: randomized controlled trial with intraindividual comparison. Plast Reconstr Surg. 2011 Oct;128(4):306e-313e. doi: 10.1097/PRS.0b013e3182268c69.
citation: Bloemen MC, van der Veer WM, Ulrich MM, van Zuijlen PP, Niessen FB, Middelkoop E. Prevention and curative management of hypertrophic scar formation. Burns. 2009 Jun;35(4):463-75. doi: 10.1016/j.burns.2008.07.016. Epub 2008 Oct 31.