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Low enrollment
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| Name | Class |
|---|---|
| Wake Forest University | OTHER |
| United States Department of Defense | FED |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KeraStat Gel | Device | Wound dressing for partial thickness burns |
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| 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 |
| 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 10 cm horizontal line ranging from 'No Pain' (0 cm) to 'Worst Pain Imaginable' (10 cm). 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 (Day 0, Day 7, Day 14, Day 21, Day 28). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James H Holmes IV, MD | Wake Forest Burn Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18843629 | Background | 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. | |
| 18653391 | 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. |
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Total Started = 14. Each participant in the study received both treatment options (2 wounds per patient - one got treated with KeraStat Gel, one got treated with Silver Sulfadiazine).
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | Each enrolled subject will have two eligible burns. One burn will be randomly assigned to the KeraStat Gel arm of the study, and the other intrabody burn will be assigned to the SSD arm of the study. The KeraStat Gel area of injury will be dressed with KeraStat Gel and covered by a secondary dressing. The SSD area of injury will be dressed with SSD and covered by a secondary dressing. Subjects will be instructed to change the dressings per instructions for use. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
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| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Each enrolled subject will have at least one eligible burn randomized to the KeraStat Gel arm and SSD arm. The KeraStat Gel area of injury will be dressed with KeraStat Gel and covered by a secondary dressing. The SSD area of injury will be dressed with SSD and covered by a secondary dressing. Subjects will be instructed to change the dressings per instructions for use. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Each subject received both KeraStat Gel and Silver Sulfadiazine. | Posted | Mean | Standard Deviation | score on a scale | One year post burn |
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Through study completion, up to 1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | KeraStat Gel-treated Wound | Each enrolled subject will have 2 wounds. One wound will be randomized to the KeraStat Gel arm and the other will be assigned the Silver Sulfadiazine arm. The KeraStat Gel area of injury will be dressed with KeraStat Gel and covered by a secondary dressing. The SSD area of injury will be dressed with SSD and covered by a secondary dressing. Subjects will be instructed to change the dressings per instructions for use. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Luke Burnett | KeraNetics | 336.725.0621 | lburnett@keranetics.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 5, 2021 | Jun 7, 2024 | Prot_SAP_001.pdf |
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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
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| Silver Sulfadiazine |
| Device |
Wound dressing for partial thickness burns |
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| 21793961 | 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. |
| 21921743 | 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. |
| 18951704 | 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. |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| OG001 | 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. Silver Sulfadiazine: Wound dressing for partial thickness burns |
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| 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 10 cm horizontal line ranging from 'No Pain' (0 cm) to 'Worst Pain Imaginable' (10 cm). The patient will mark the line to represent his or her level of pain before and after dressing changes. | Each participant received KeraStat Gel and Silver Sulfadiazine. | Posted | Mean | Standard Deviation | score on a scale | Period during first month when dressing changes are required (Day 0, Day 7, Day 14, Day 21, Day 28). |
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| 0 |
| 14 |
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| 14 |
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| 14 |
| EG001 | Silver Sulfadiazine-treated Wound | Each enrolled subject will have 2 wounds. One wound will be randomized to the KeraStat Gel arm and the other will be assigned the Silver Sulfadiazine arm. The KeraStat Gel area of injury will be dressed with KeraStat Gel and covered by a secondary dressing. The SSD area of injury will be dressed with SSD and covered by a secondary dressing. Subjects will be instructed to change the dressings per instructions for use. | 0 | 14 | 0 | 14 | 0 | 14 |
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| Day 0 - Pain Score During Dressing Change - KeraStat Gel |
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| Day 0 - Pain Score During Dressing Change - SSD |
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| Day 0 - Pain Score Immediately Following Dressing Change - KeraStat Gel |
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| Day 0 - Pain Score Immediately Following Dressing Change - SSD |
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| Day 0 - Pain Score 15 Minutes After Dressing Change - KeraStat Gel |
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| Day 0 - Pain Score 15 Minutes After Dressing Change - SSD |
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| Day 7 - Pain Score Immediately Prior to Dressing Change - KeraStat Gel |
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| Day 7 - Pain Score Immediately Prior to Dressing Change - SSD |
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| Day 7 - Pain Score During Dressing Change - KeraStat Gel |
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| Day 7 - Pain Score During Dressing Change - SSD |
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| Day 7 - Pain Score Immediately Following Dressing Change - KeraStat Gel |
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| Day 7 - Pain Score Immediately Following Dressing Change - SSD |
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| Day 7 - Pain Score 15 Minutes After Dressing Change - KeraStat Gel |
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| Day 7 - Pain Score 15 Minutes After Dressing Change - SSD |
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| Day 14 - Pain Score Immediately Prior to Dressing Change - KeraStat Gel |
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| Day 14 - Pain Score Immediately Prior to Dressing Change - SSD |
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| Day 14 - Pain Score During Dressing Change - KeraStat Gel |
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| Day 14 - Pain Score During Dressing Change - SSD |
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| Day 14 - Pain Score Immediately Following Dressing Change - KeraStat Gel |
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| Day 14 - Pain Score Immediately Following Dressing Change - SSD |
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| Day 14 - Pain Score 15 Minutes After Dressing Change - KeraStat Gel |
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| Day 14 - Pain Score 15 Minutes After Dressing Change - SSD |
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| Day 21 - Pain Score Immediately Prior to Dressing Change - KeraStat Gel |
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| Day 21 - Pain Score Immediately Prior to Dressing Change - SSD |
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| Day 21 - Pain Score During Dressing Change - KeraStat Gel |
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| Day 21 - Pain Score During Dressing Change - SSD |
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| Day 21 - Pain Score Immediately After Dressing Change - KeraStat Gel |
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| Day 21 - Pain Score Immediately After Dressing Change - SSD |
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| Day 21 - Pain Score 15 Minutes After Dressing Change - KeraStat Gel |
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| Day 21 - Pain Score 15 Minutes After Dressing Change - SSD |
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| Day 28 - Pain Score Immediately Prior to Dressing Change - KeraStat Gel |
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| Day 28 - Pain Score Immediately Prior to Dressing Change - SSD |
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| Day 28 - Pain Score During Dressing Change - KeraStat Gel |
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| Day 28 - Pain Score During Dressing Change - SSD |
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| Day 28 - Pain Score Immediately Following Dressing Change - KeraStat Gel |
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| Day 28 - Pain Score Immediately Following Dressing Change - SSD |
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| Day 28 - Pain Score 15 Minutes After Dressing Change - KeraStat Gel |
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| Day 28 - Pain Score 15 Minutes After Dressing Change - SSD |
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