Effectiveness of KeraStat Gel for Improved Cosmesis of Partial Thickness Burns

Partial-thickness Burn Clinical Trial

Official title:

Effectiveness of KeraStat Gel for Improved Cosmesis of Partial Thickness Burns

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03564795
• Other study ID #: KSGL-CRD-003
• Status: Recruiting
• Phase: N/A
• Start date: August 31, 2018
• Est. completion date: October 31, 2022

Study information

• Verified date: September 2021
• Source: KeraNetics, LLC
• Contact: Alexis Rejeski Gabard, MS
• Phone: 336-575-2278
• Email: alexis.gabard[@]keranetics.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: October 31, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 100 Years

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

Related Conditions & MeSH terms

• Burns
• Partial-thickness Burn

Intervention

Device:
• KeraStat Gel
Wound dressing for partial thickness burns
• Silver Sulfadiazine
Wound dressing for partial thickness burns

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
KeraNetics, LLC	United States Department of Defense, Wake Forest University

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. Review. — View 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:s16-21. doi: 10.1111/j.1524-475X.2011.00709.x. Review. — View 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. — View 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. — View 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. Review. Update in: Cochrane Database Syst Rev. 2013;3:CD002106. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Time to Reepithelialization	Digital Images will be taken weekly over the first month in order to assess % reepithelialization	First Month
Secondary	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)