Effectiveness of KeraStat Gel for Improved Cosmesis of Partial Thickness Burns

NCT03564795 | Terminated Results FDA Device

• 1 other identifier: KSGL-CRD-003
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Partial-thickness Burn

Keywords

Wound Dressing; Keratin; Hydrogel; Burn Dressing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Pain During Dressing Change

  Period during first month when dressing changes are required (Day 0, Day 7, Day 14, Day 21, Day 28).

Study Arms (2)

KeraStat Gel

EXPERIMENTAL

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

Silver Sulfadiazine

ACTIVE COMPARATOR

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

Interventions

KeraStat Gel DEVICE

Wound dressing for partial thickness burns

KeraStat Gel

Silver Sulfadiazine DEVICE

Wound dressing for partial thickness burns

Also known as: SSD

Silver Sulfadiazine

Eligibility Criteria

• Age: 6 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• KeraNetics, LLC: lead
• Wake Forest University: collaborator
• United States Department of Defense: collaborator

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (5)

• 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.

  PMID: 18843629 BACKGROUND

• 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.

  PMID: 18653391 BACKGROUND

• 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.

  PMID: 21793961 BACKGROUND

• 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.

  PMID: 21921743 BACKGROUND

• 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.

  PMID: 18951704 BACKGROUND

Results Point of Contact

• Title: Luke Burnett
• Organization: KeraNetics

lburnett@keranetics.com

336.725.0621

Study Officials

• James H Holmes IV, MD

  Wake Forest Burn Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: June 11, 2018
• First Posted: June 21, 2018
• Study Start: August 31, 2018
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: August 1, 2024
• Results First Posted: August 1, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)