Partial-thickness Burn
Conditions
Keywords
Wound Dressing, Keratin, Hydrogel, Burn Dressing
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.
Interventions
DEVICEKeraStat Gel
Wound dressing for partial thickness burns
DEVICESilver Sulfadiazine
Wound dressing for partial thickness burns
Sponsors
Wake Forest University
United States Department of Defense
KeraNetics, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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
Eligibility
Sex/Gender
ALL
Age
6 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improved Cosmesis | One year post burn | 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
| Measure | Time frame | Description |
|---|---|---|
| Pain During Dressing Change | Period during first month when dressing changes are required (Day 0, Day 7, Day 14, Day 21, Day 28). | 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. |
Countries
United States
Participant flow
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| 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. | 14 |
| Total | 14 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 6 |
| Overall Study | Physician Decision | 2 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Categorical <=18 years | 1 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants |
| Age, Continuous | 38.07 years STANDARD_DEVIATION 16.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 11 Participants |
| Region of Enrollment United States | 14 Participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 14 |
| other Total, other adverse events | 0 / 14 | 0 / 14 |
| serious Total, serious adverse events | 0 / 14 | 0 / 14 |
Outcome results
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.
Time frame: One year post burn
Population: Each subject received both KeraStat Gel and Silver Sulfadiazine.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| KeraStat Gel | Improved Cosmesis | POSAS - Observer (3 Month) | 12 score on a scale | Standard Deviation 5.86 |
| KeraStat Gel | Improved Cosmesis | POSAS - Observer (6 Month) | 10 score on a scale | Standard Deviation 3.24 |
| KeraStat Gel | Improved Cosmesis | POSAS - Observer (12 Month) | 7.67 score on a scale | Standard Deviation 2.89 |
| KeraStat Gel | Improved Cosmesis | POSAS - Patient (3 Month) | 4.125 score on a scale | Standard Deviation 2.85 |
| KeraStat Gel | Improved Cosmesis | POSAS - Patient (6 Month) | 5.4 score on a scale | Standard Deviation 4.34 |
| KeraStat Gel | Improved Cosmesis | POSAS - Patient (12 Month) | 6 score on a scale | Standard Deviation 4.36 |
| Silver Sulfadiazine | Improved Cosmesis | POSAS - Patient (6 Month) | 5.2 score on a scale | Standard Deviation 4.09 |
| Silver Sulfadiazine | Improved Cosmesis | POSAS - Observer (3 Month) | 12.125 score on a scale | Standard Deviation 5.62 |
| Silver Sulfadiazine | Improved Cosmesis | POSAS - Patient (3 Month) | 4.875 score on a scale | Standard Deviation 2.95 |
| Silver Sulfadiazine | Improved Cosmesis | POSAS - Observer (6 Month) | 10 score on a scale | Standard Deviation 2.92 |
| Silver Sulfadiazine | Improved Cosmesis | POSAS - Patient (12 Month) | 4.67 score on a scale | Standard Deviation 3.51 |
| Silver Sulfadiazine | Improved Cosmesis | POSAS - Observer (12 Month) | 6 score on a scale | Standard Deviation 4.36 |
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.
Time frame: Period during first month when dressing changes are required (Day 0, Day 7, Day 14, Day 21, Day 28).
Population: Each participant received KeraStat Gel and Silver Sulfadiazine.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| KeraStat Gel | Pain During Dressing Change | Day 0 - Pain Score Immediately Prior to Dressing Change - KeraStat Gel | 3.14 score on a scale | Standard Deviation 3.74 |
| KeraStat Gel | Pain During Dressing Change | Day 0 - Pain Score Immediately Prior to Dressing Change - SSD | 2.86 score on a scale | Standard Deviation 3.39 |
| KeraStat Gel | Pain During Dressing Change | Day 0 - Pain Score During Dressing Change - KeraStat Gel | 4.14 score on a scale | Standard Deviation 3.51 |
| KeraStat Gel | Pain During Dressing Change | Day 0 - Pain Score During Dressing Change - SSD | 4.00 score on a scale | Standard Deviation 3.46 |
| KeraStat Gel | Pain During Dressing Change | Day 0 - Pain Score Immediately Following Dressing Change - KeraStat Gel | 4.14 score on a scale | Standard Deviation 3.68 |
| KeraStat Gel | Pain During Dressing Change | Day 0 - Pain Score Immediately Following Dressing Change - SSD | 3.64 score on a scale | Standard Deviation 3.32 |
| KeraStat Gel | Pain During Dressing Change | Day 0 - Pain Score 15 Minutes After Dressing Change - KeraStat Gel | 4.07 score on a scale | Standard Deviation 3.38 |
| KeraStat Gel | Pain During Dressing Change | Day 0 - Pain Score 15 Minutes After Dressing Change - SSD | 3.42 score on a scale | Standard Deviation 2.93 |
| KeraStat Gel | Pain During Dressing Change | Day 7 - Pain Score Immediately Prior to Dressing Change - KeraStat Gel | 2.57 score on a scale | Standard Deviation 3.55 |
| KeraStat Gel | Pain During Dressing Change | Day 7 - Pain Score Immediately Prior to Dressing Change - SSD | 3.00 score on a scale | Standard Deviation 3.7 |
| KeraStat Gel | Pain During Dressing Change | Day 7 - Pain Score During Dressing Change - KeraStat Gel | 3.86 score on a scale | Standard Deviation 4.34 |
| KeraStat Gel | Pain During Dressing Change | Day 7 - Pain Score During Dressing Change - SSD | 4.00 score on a scale | Standard Deviation 4.32 |
| KeraStat Gel | Pain During Dressing Change | Day 7 - Pain Score Immediately Following Dressing Change - KeraStat Gel | 3.29 score on a scale | Standard Deviation 3.73 |
| KeraStat Gel | Pain During Dressing Change | Day 7 - Pain Score Immediately Following Dressing Change - SSD | 3.57 score on a scale | Standard Deviation 3.95 |
| KeraStat Gel | Pain During Dressing Change | Day 7 - Pain Score 15 Minutes After Dressing Change - KeraStat Gel | 2.71 score on a scale | Standard Deviation 3.09 |
| KeraStat Gel | Pain During Dressing Change | Day 7 - Pain Score 15 Minutes After Dressing Change - SSD | 3.00 score on a scale | Standard Deviation 3.37 |
| KeraStat Gel | Pain During Dressing Change | Day 14 - Pain Score Immediately Prior to Dressing Change - KeraStat Gel | 1.80 score on a scale | Standard Deviation 1.48 |
| KeraStat Gel | Pain During Dressing Change | Day 14 - Pain Score Immediately Prior to Dressing Change - SSD | 1.20 score on a scale | Standard Deviation 1.1 |
| KeraStat Gel | Pain During Dressing Change | Day 14 - Pain Score During Dressing Change - KeraStat Gel | 2.00 score on a scale | Standard Deviation 1.58 |
| KeraStat Gel | Pain During Dressing Change | Day 14 - Pain Score During Dressing Change - SSD | 1.40 score on a scale | Standard Deviation 1.34 |
| KeraStat Gel | Pain During Dressing Change | Day 14 - Pain Score Immediately Following Dressing Change - KeraStat Gel | 1.90 score on a scale | Standard Deviation 1.88 |
| KeraStat Gel | Pain During Dressing Change | Day 14 - Pain Score Immediately Following Dressing Change - SSD | 1.50 score on a scale | Standard Deviation 1.5 |
| KeraStat Gel | Pain During Dressing Change | Day 14 - Pain Score 15 Minutes After Dressing Change - KeraStat Gel | 1.70 score on a scale | Standard Deviation 1.64 |
| KeraStat Gel | Pain During Dressing Change | Day 14 - Pain Score 15 Minutes After Dressing Change - SSD | 1.30 score on a scale | Standard Deviation 1.48 |
| KeraStat Gel | Pain During Dressing Change | Day 21 - Pain Score Immediately Prior to Dressing Change - KeraStat Gel | 1.00 score on a scale | Standard Deviation 1 |
| KeraStat Gel | Pain During Dressing Change | Day 21 - Pain Score Immediately Prior to Dressing Change - SSD | 0.33 score on a scale | Standard Deviation 0.58 |
| KeraStat Gel | Pain During Dressing Change | Day 21 - Pain Score During Dressing Change - KeraStat Gel | 1.00 score on a scale | Standard Deviation 1 |
| KeraStat Gel | Pain During Dressing Change | Day 21 - Pain Score During Dressing Change - SSD | 0.33 score on a scale | Standard Deviation 0.58 |
| KeraStat Gel | Pain During Dressing Change | Day 21 - Pain Score Immediately After Dressing Change - KeraStat Gel | 1.00 score on a scale | Standard Deviation 1 |
| KeraStat Gel | Pain During Dressing Change | Day 21 - Pain Score Immediately After Dressing Change - SSD | 0.33 score on a scale | Standard Deviation 0.58 |
| KeraStat Gel | Pain During Dressing Change | Day 21 - Pain Score 15 Minutes After Dressing Change - KeraStat Gel | 1.00 score on a scale | Standard Deviation 1 |
| KeraStat Gel | Pain During Dressing Change | Day 21 - Pain Score 15 Minutes After Dressing Change - SSD | 0.33 score on a scale | Standard Deviation 0.58 |
| KeraStat Gel | Pain During Dressing Change | Day 28 - Pain Score Immediately Prior to Dressing Change - KeraStat Gel | 1.00 score on a scale | — |
| KeraStat Gel | Pain During Dressing Change | Day 28 - Pain Score Immediately Prior to Dressing Change - SSD | 1.00 score on a scale | — |
| KeraStat Gel | Pain During Dressing Change | Day 28 - Pain Score During Dressing Change - KeraStat Gel | 1.00 score on a scale | — |
| KeraStat Gel | Pain During Dressing Change | Day 28 - Pain Score During Dressing Change - SSD | 1.00 score on a scale | — |
| KeraStat Gel | Pain During Dressing Change | Day 28 - Pain Score Immediately Following Dressing Change - KeraStat Gel | 1.00 score on a scale | — |
| KeraStat Gel | Pain During Dressing Change | Day 28 - Pain Score Immediately Following Dressing Change - SSD | 1.00 score on a scale | — |
| KeraStat Gel | Pain During Dressing Change | Day 28 - Pain Score 15 Minutes After Dressing Change - KeraStat Gel | 1.00 score on a scale | — |
| KeraStat Gel | Pain During Dressing Change | Day 28 - Pain Score 15 Minutes After Dressing Change - SSD | 1.00 score on a scale | — |