Effectiveness of KeraStat Gel for Improved Cosmesis of Partial Thickness Burns

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.

Study Overview

• Status: Recruiting
• Conditions: Partial-thickness Burn
• Intervention / Treatment: Device: KeraStat Gel; Device: Silver Sulfadiazine

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alexis Rejeski Gabard, MS; Phone Number: 336-575-2278; Email: alexis.gabard@keranetics.com
• Study Contact Backup: Name: Luke Burnett, PhD; Phone Number: 336-202-1307; Email: luke.burnett@keranetics.com

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Recruiting
      • Wake Forest University Health Sciences
      • Contact: James H Holmes, MD; Phone Number: 336-716-8040; Email: jholmes@wakehealth.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 100 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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).	Device: KeraStat Gel; Wound dressing for partial thickness burns
ACTIVE_COMPARATOR: 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.	Device: Silver Sulfadiazine; Wound dressing for partial thickness burns; Other Names: SSD

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: KeraNetics, LLC
• Collaborators: United States Department of Defense; Wake Forest University
• Investigators: Principal Investigator: James H Holmes IV, MD, Wake Forest Burn Center

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 31, 2018
• Primary Completion (ANTICIPATED): October 31, 2022
• Study Completion (ANTICIPATED): October 31, 2022

Study Registration Dates

• First Submitted: June 11, 2018
• First Submitted That Met QC Criteria: June 19, 2018
• First Posted (ACTUAL): June 21, 2018

Study Record Updates

• Last Update Posted (ACTUAL): September 8, 2021
• Last Update Submitted That Met QC Criteria: September 5, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Hydrogel; Wound Dressing; Keratin; Burn Dressing
• Additional Relevant MeSH Terms: Wounds and Injuries; Burns; Anti-Infective Agents, Local; Anti-Infective Agents; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents; Coccidiostats; Sulfadiazine; Silver Sulfadiazine
• Other Study ID Numbers: KSGL-CRD-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No