An interventional study of KeraStat Gel and Silver Sulfadiazine in Partial-thickness Burn, sponsored by KeraNetics, LLC. Terminated at 1 site in United States. Open to participants aged 6 Years to 100 Years. Per ClinicalTrials.gov, last updated 2024-08-01.
Sponsored by KeraNetics, LLC · Not applicable, Interventional, and Treatment
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.
719 studies on the registry are indexed under Burns; 145 are open to participants now.
This study's enrollment of 14 is below the median of 40 across 524 interventional studies indexed under Burns.
Browse Burns studies →KeraNetics, LLC is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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
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
Wound dressing for partial thickness burns
Wound dressing for partial thickness burns
Also known as: SSD
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
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).
| Milestone | All Participants |
|---|---|
| Started | 14 |
| Kerastat gel-treated: | 14 |
| Silver sulfadiazine-treated: | 14 |
| Completed | 3 |
| Not completed | 11 |
| Withdrew: Withdrawal by subject | 3 |
| Withdrew: Lost to follow-up | 6 |
| Withdrew: Physician decision | 2 |
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.
| score on a scale | KeraStat Gel | Silver Sulfadiazine |
|---|---|---|
| POSAS - Observer (3 Month) | 12 ± 5.86 | 12.125 ± 5.62 |
| POSAS - Observer (6 Month) | 10 ± 3.24 | 10 ± 2.92 |
| POSAS - Observer (12 Month) | 7.67 ± 2.89 | 6 ± 4.36 |
| POSAS - Patient (3 Month) | 4.125 ± 2.85 | 4.875 ± 2.95 |
| POSAS - Patient (6 Month) | 5.4 ± 4.34 | 5.2 ± 4.09 |
| POSAS - Patient (12 Month) | 6 ± 4.36 | 4.67 ± 3.51 |
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.
| score on a scale | All Participants |
|---|---|
| Day 0 - Pain Score Immediately Prior to Dressing Change - KeraStat Gel | 3.14 ± 3.74 |
| Day 0 - Pain Score Immediately Prior to Dressing Change - SSD | 2.86 ± 3.39 |
| Day 0 - Pain Score During Dressing Change - KeraStat Gel | 4.14 ± 3.51 |
| Day 0 - Pain Score During Dressing Change - SSD | 4.00 ± 3.46 |
| Day 0 - Pain Score Immediately Following Dressing Change - KeraStat Gel | 4.14 ± 3.68 |
| Day 0 - Pain Score Immediately Following Dressing Change - SSD | 3.64 ± 3.32 |
| Day 0 - Pain Score 15 Minutes After Dressing Change - KeraStat Gel | 4.07 ± 3.38 |
| Day 0 - Pain Score 15 Minutes After Dressing Change - SSD | 3.42 ± 2.93 |
| Day 7 - Pain Score Immediately Prior to Dressing Change - KeraStat Gel | 2.57 ± 3.55 |
| Day 7 - Pain Score Immediately Prior to Dressing Change - SSD | 3.00 ± 3.70 |
| Day 7 - Pain Score During Dressing Change - KeraStat Gel | 3.86 ± 4.34 |
| Day 7 - Pain Score During Dressing Change - SSD | 4.00 ± 4.32 |
| Day 7 - Pain Score Immediately Following Dressing Change - KeraStat Gel | 3.29 ± 3.73 |
| Day 7 - Pain Score Immediately Following Dressing Change - SSD | 3.57 ± 3.95 |
| Day 7 - Pain Score 15 Minutes After Dressing Change - KeraStat Gel | 2.71 ± 3.09 |
| Day 7 - Pain Score 15 Minutes After Dressing Change - SSD | 3.00 ± 3.37 |
| Day 14 - Pain Score Immediately Prior to Dressing Change - KeraStat Gel | 1.80 ± 1.48 |
| Day 14 - Pain Score Immediately Prior to Dressing Change - SSD | 1.20 ± 1.10 |
| Day 14 - Pain Score During Dressing Change - KeraStat Gel | 2.00 ± 1.58 |
| Day 14 - Pain Score During Dressing Change - SSD | 1.40 ± 1.34 |
| Day 14 - Pain Score Immediately Following Dressing Change - KeraStat Gel | 1.90 ± 1.88 |
| Day 14 - Pain Score Immediately Following Dressing Change - SSD | 1.50 ± 1.50 |
| Day 14 - Pain Score 15 Minutes After Dressing Change - KeraStat Gel | 1.70 ± 1.64 |
| Day 14 - Pain Score 15 Minutes After Dressing Change - SSD | 1.30 ± 1.48 |
| Day 21 - Pain Score Immediately Prior to Dressing Change - KeraStat Gel | 1.00 ± 1.00 |
| Day 21 - Pain Score Immediately Prior to Dressing Change - SSD | 0.33 ± 0.58 |
| Day 21 - Pain Score During Dressing Change - KeraStat Gel | 1.00 ± 1.00 |
| Day 21 - Pain Score During Dressing Change - SSD | 0.33 ± 0.58 |
| Day 21 - Pain Score Immediately After Dressing Change - KeraStat Gel | 1.00 ± 1.00 |
| Day 21 - Pain Score Immediately After Dressing Change - SSD | 0.33 ± 0.58 |
| Day 21 - Pain Score 15 Minutes After Dressing Change - KeraStat Gel | 1.00 ± 1.00 |
| Day 21 - Pain Score 15 Minutes After Dressing Change - SSD | 0.33 ± 0.58 |
| Day 28 - Pain Score Immediately Prior to Dressing Change - KeraStat Gel | 1.00 ± NA |
| Day 28 - Pain Score Immediately Prior to Dressing Change - SSD | 1.00 ± NA |
| Day 28 - Pain Score During Dressing Change - KeraStat Gel | 1.00 ± NA |
| Day 28 - Pain Score During Dressing Change - SSD | 1.00 ± NA |
| Day 28 - Pain Score Immediately Following Dressing Change - KeraStat Gel | 1.00 ± NA |
| Day 28 - Pain Score Immediately Following Dressing Change - SSD | 1.00 ± NA |
| Day 28 - Pain Score 15 Minutes After Dressing Change - KeraStat Gel | 1.00 ± NA |
| Day 28 - Pain Score 15 Minutes After Dressing Change - SSD | 1.00 ± NA |
Collected over Through study completion, up to 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| KeraStat Gel-treated Wound | 0/14 (0%) | 0/14 (0%) | 0/14 (0%) |
| Silver Sulfadiazine-treated Wound | 0/14 (0%) | 0/14 (0%) | 0/14 (0%) |
| Age, Categorical(Participants) | All Participants |
|---|---|
| <=18 years | 1 |
| Between 18 and 65 years | 13 |
| >=65 years | 0 |
| Age, Continuous(years) | All Participants |
|---|---|
| Mean | 38.07 ± 16.9 |
| Sex: Female, Male(Participants) | All Participants |
|---|---|
| Female | 1 |
| Male | 13 |
| Race (NIH/OMB)(Participants) | All Participants |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 3 |
| White | 11 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | All Participants |
|---|---|
| United States | 14 |
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