Trial Outcomes & Findings for Effectiveness of KeraStat Gel for Improved Cosmesis of Partial Thickness Burns (NCT NCT03564795)
NCT ID: NCT03564795
Last Updated: 2024-08-01
Results Overview
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.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
14 participants
Primary outcome timeframe
One year post burn
Results posted on
2024-08-01
Participant Flow
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).
Unit of analysis: Wounds
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
14 28
|
|
Overall Study
KeraStat Gel-treated:
|
14 14
|
|
Overall Study
Silver Sulfadiazine-treated:
|
14 14
|
|
Overall Study
COMPLETED
|
3 6
|
|
Overall Study
NOT COMPLETED
|
11 22
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Lost to Follow-up
|
6
|
|
Overall Study
Physician Decision
|
2
|
Baseline Characteristics
Effectiveness of KeraStat Gel for Improved Cosmesis of Partial Thickness Burns
Baseline characteristics by cohort
| Measure |
All Participants
n=14 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.
|
|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
38.07 years
STANDARD_DEVIATION 16.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: One year post burnPopulation: Each subject received both KeraStat Gel and Silver Sulfadiazine.
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.
Outcome measures
| Measure |
KeraStat Gel
n=14 Participants
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).
KeraStat Gel: Wound dressing for partial thickness burns
|
Silver Sulfadiazine
n=14 Participants
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
|
|---|---|---|
|
Improved Cosmesis
POSAS - Observer (3 Month)
|
12 score on a scale
Standard Deviation 5.86
|
12.125 score on a scale
Standard Deviation 5.62
|
|
Improved Cosmesis
POSAS - Observer (6 Month)
|
10 score on a scale
Standard Deviation 3.24
|
10 score on a scale
Standard Deviation 2.92
|
|
Improved Cosmesis
POSAS - Observer (12 Month)
|
7.67 score on a scale
Standard Deviation 2.89
|
6 score on a scale
Standard Deviation 4.36
|
|
Improved Cosmesis
POSAS - Patient (3 Month)
|
4.125 score on a scale
Standard Deviation 2.85
|
4.875 score on a scale
Standard Deviation 2.95
|
|
Improved Cosmesis
POSAS - Patient (6 Month)
|
5.4 score on a scale
Standard Deviation 4.34
|
5.2 score on a scale
Standard Deviation 4.09
|
|
Improved Cosmesis
POSAS - Patient (12 Month)
|
6 score on a scale
Standard Deviation 4.36
|
4.67 score on a scale
Standard Deviation 3.51
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
KeraStat Gel
n=14 Participants
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).
KeraStat Gel: Wound dressing for partial thickness burns
|
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
|
|---|---|---|
|
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
|
—
|
|
Pain During Dressing Change
Day 0 - Pain Score 15 Minutes After Dressing Change - SSD
|
3.42 score on a scale
Standard Deviation 2.93
|
—
|
|
Pain During Dressing Change
Day 21 - Pain Score Immediately Prior to Dressing Change - SSD
|
0.33 score on a scale
Standard Deviation 0.58
|
—
|
|
Pain During Dressing Change
Day 21 - Pain Score During Dressing Change - KeraStat Gel
|
1.00 score on a scale
Standard Deviation 1.00
|
—
|
|
Pain During Dressing Change
Day 21 - Pain Score During Dressing Change - SSD
|
0.33 score on a scale
Standard Deviation 0.58
|
—
|
|
Pain During Dressing Change
Day 21 - Pain Score Immediately After Dressing Change - KeraStat Gel
|
1.00 score on a scale
Standard Deviation 1.00
|
—
|
|
Pain During Dressing Change
Day 21 - Pain Score Immediately After Dressing Change - SSD
|
0.33 score on a scale
Standard Deviation 0.58
|
—
|
|
Pain During Dressing Change
Day 21 - Pain Score 15 Minutes After Dressing Change - KeraStat Gel
|
1.00 score on a scale
Standard Deviation 1.00
|
—
|
|
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
|
—
|
|
Pain During Dressing Change
Day 0 - Pain Score Immediately Prior to Dressing Change - SSD
|
2.86 score on a scale
Standard Deviation 3.39
|
—
|
|
Pain During Dressing Change
Day 0 - Pain Score During Dressing Change - KeraStat Gel
|
4.14 score on a scale
Standard Deviation 3.51
|
—
|
|
Pain During Dressing Change
Day 0 - Pain Score During Dressing Change - SSD
|
4.00 score on a scale
Standard Deviation 3.46
|
—
|
|
Pain During Dressing Change
Day 0 - Pain Score Immediately Following Dressing Change - KeraStat Gel
|
4.14 score on a scale
Standard Deviation 3.68
|
—
|
|
Pain During Dressing Change
Day 0 - Pain Score Immediately Following Dressing Change - SSD
|
3.64 score on a scale
Standard Deviation 3.32
|
—
|
|
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
|
—
|
|
Pain During Dressing Change
Day 7 - Pain Score Immediately Prior to Dressing Change - SSD
|
3.00 score on a scale
Standard Deviation 3.70
|
—
|
|
Pain During Dressing Change
Day 7 - Pain Score During Dressing Change - KeraStat Gel
|
3.86 score on a scale
Standard Deviation 4.34
|
—
|
|
Pain During Dressing Change
Day 7 - Pain Score Immediately Following Dressing Change - KeraStat Gel
|
3.29 score on a scale
Standard Deviation 3.73
|
—
|
|
Pain During Dressing Change
Day 7 - Pain Score Immediately Following Dressing Change - SSD
|
3.57 score on a scale
Standard Deviation 3.95
|
—
|
|
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
|
—
|
|
Pain During Dressing Change
Day 21 - Pain Score 15 Minutes After Dressing Change - SSD
|
0.33 score on a scale
Standard Deviation 0.58
|
—
|
|
Pain During Dressing Change
Day 7 - Pain Score 15 Minutes After Dressing Change - SSD
|
3.00 score on a scale
Standard Deviation 3.37
|
—
|
|
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
|
—
|
|
Pain During Dressing Change
Day 14 - Pain Score Immediately Prior to Dressing Change - SSD
|
1.20 score on a scale
Standard Deviation 1.10
|
—
|
|
Pain During Dressing Change
Day 14 - Pain Score During Dressing Change - KeraStat Gel
|
2.00 score on a scale
Standard Deviation 1.58
|
—
|
|
Pain During Dressing Change
Day 14 - Pain Score During Dressing Change - SSD
|
1.40 score on a scale
Standard Deviation 1.34
|
—
|
|
Pain During Dressing Change
Day 7 - Pain Score During Dressing Change - SSD
|
4.00 score on a scale
Standard Deviation 4.32
|
—
|
|
Pain During Dressing Change
Day 28 - Pain Score Immediately Prior to Dressing Change - KeraStat Gel
|
1.00 score on a scale
Standard Deviation NA
Insufficient participants to generate standard deviation.
|
—
|
|
Pain During Dressing Change
Day 14 - Pain Score Immediately Following Dressing Change - KeraStat Gel
|
1.90 score on a scale
Standard Deviation 1.88
|
—
|
|
Pain During Dressing Change
Day 14 - Pain Score Immediately Following Dressing Change - SSD
|
1.50 score on a scale
Standard Deviation 1.50
|
—
|
|
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
|
—
|
|
Pain During Dressing Change
Day 14 - Pain Score 15 Minutes After Dressing Change - SSD
|
1.30 score on a scale
Standard Deviation 1.48
|
—
|
|
Pain During Dressing Change
Day 21 - Pain Score Immediately Prior to Dressing Change - KeraStat Gel
|
1.00 score on a scale
Standard Deviation 1.00
|
—
|
|
Pain During Dressing Change
Day 28 - Pain Score Immediately Prior to Dressing Change - SSD
|
1.00 score on a scale
Standard Deviation NA
Insufficient participants to generate standard deviation.
|
—
|
|
Pain During Dressing Change
Day 28 - Pain Score During Dressing Change - KeraStat Gel
|
1.00 score on a scale
Standard Deviation NA
Insufficient participants to generate standard deviation.
|
—
|
|
Pain During Dressing Change
Day 28 - Pain Score During Dressing Change - SSD
|
1.00 score on a scale
Standard Deviation NA
Insufficient participants to generate standard deviation.
|
—
|
|
Pain During Dressing Change
Day 28 - Pain Score Immediately Following Dressing Change - KeraStat Gel
|
1.00 score on a scale
Standard Deviation NA
Insufficient participants to generate standard deviation.
|
—
|
|
Pain During Dressing Change
Day 28 - Pain Score Immediately Following Dressing Change - SSD
|
1.00 score on a scale
Standard Deviation NA
Insufficient participants to generate standard deviation.
|
—
|
|
Pain During Dressing Change
Day 28 - Pain Score 15 Minutes After Dressing Change - KeraStat Gel
|
1.00 score on a scale
Standard Deviation NA
Insufficient participants to generate standard deviation.
|
—
|
|
Pain During Dressing Change
Day 28 - Pain Score 15 Minutes After Dressing Change - SSD
|
1.00 score on a scale
Standard Deviation NA
Insufficient participants to generate standard deviation.
|
—
|
Adverse Events
KeraStat Gel-treated Wound
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Silver Sulfadiazine-treated Wound
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place