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Effectiveness of KeraStat Gel for Improved Cosmesis of Partial Thickness Burns

Primary Purpose

Partial-thickness Burn

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
KeraStat Gel
Silver Sulfadiazine
Sponsored by
KeraNetics, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Partial-thickness Burn focused on measuring Wound Dressing, Keratin, Hydrogel, Burn Dressing

Eligibility Criteria

6 Years - 100 Years (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Wake Forest University Health SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

KeraStat Gel

Silver Sulfadiazine

Arm 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).

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Time to Reepithelialization
Digital Images will be taken weekly over the first month in order to assess % reepithelialization
Need for Excision and Grafting
The need for excision and/or grafting will be documented for each treated burn for each subject

Full Information

First Posted
June 11, 2018
Last Updated
September 5, 2021
Sponsor
KeraNetics, LLC
Collaborators
Wake Forest University, United States Department of Defense
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1. Study Identification

Unique Protocol Identification Number
NCT03564795
Brief Title
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

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 31, 2018 (Actual)
Primary Completion Date
October 31, 2022 (Anticipated)
Study Completion Date
October 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
KeraNetics, LLC
Collaborators
Wake Forest University, United States Department of Defense

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Partial-thickness Burn
Keywords
Wound Dressing, Keratin, Hydrogel, Burn Dressing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
KeraStat Gel
Arm Type
Experimental
Arm 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).
Arm Title
Silver Sulfadiazine
Arm Type
Active Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
KeraStat Gel
Intervention Description
Wound dressing for partial thickness burns
Intervention Type
Device
Intervention Name(s)
Silver Sulfadiazine
Other Intervention Name(s)
SSD
Intervention Description
Wound dressing for partial thickness burns
Primary Outcome Measure Information:
Title
Improved Cosmesis
Description
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.
Time Frame
One year post burn
Secondary Outcome Measure Information:
Title
Pain during Dressing Change
Description
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.
Time Frame
Period during first month when dressing changes are required
Title
Time to Reepithelialization
Description
Digital Images will be taken weekly over the first month in order to assess % reepithelialization
Time Frame
First Month
Title
Need for Excision and Grafting
Description
The need for excision and/or grafting will be documented for each treated burn for each subject
Time Frame
Entire study (one year)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexis Rejeski Gabard, MS
Phone
336-575-2278
Email
alexis.gabard@keranetics.com
First Name & Middle Initial & Last Name or Official Title & Degree
Luke Burnett, PhD
Phone
336-202-1307
Email
luke.burnett@keranetics.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James H Holmes IV, MD
Organizational Affiliation
Wake Forest Burn Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James H Holmes, MD
Phone
336-716-8040
Email
jholmes@wakehealth.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
18843629
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.
Results Reference
background
PubMed Identifier
18653391
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.
Results Reference
background
PubMed Identifier
21793961
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.
Results Reference
background
PubMed Identifier
21921743
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.
Results Reference
background
PubMed Identifier
18951704
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.
Results Reference
background

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Effectiveness of KeraStat Gel for Improved Cosmesis of Partial Thickness Burns

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