Trial Outcomes & Findings for Comparison of Collagenase With Antibiotic Ointment of Minor Partial Thickness Burns (NCT NCT02673229)
NCT ID: NCT02673229
Last Updated: 2024-07-10
Results Overview
Outcome will be reported as number of subjects with at least 95% wound healing
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
20 participants
Primary outcome timeframe
21 Days After Treatment
Results posted on
2024-07-10
Participant Flow
Participant milestones
| Measure |
Collagenase Santyl
Applied topically (2 mm thickness once daily)
Collagenase Santyl: A sterile, enzymatic debriding agent which contains 250 collagenase units per gram of white petrolatum, United States Pharmacopeia (USP).
|
Bacitracin
Applied topically (2 mm thickness) once daily
Bacitracin: One gram is equal to 500 bacitracin units; one unit of bacitracin is equivalent to 0.026 milligrams.
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
12
|
|
Overall Study
COMPLETED
|
7
|
9
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of Collagenase With Antibiotic Ointment of Minor Partial Thickness Burns
Baseline characteristics by cohort
| Measure |
Bacitracin
n=12 Participants
Applied topically (2 mm thickness) once daily
Bacitracin: One gram is equal to 500 bacitracin units; one unit of bacitracin is equivalent to 0.026 milligrams.
|
Total
n=20 Participants
Total of all reporting groups
|
Collagenase Santyl
n=8 Participants
Applied topically (2 mm thickness once daily)
Collagenase Santyl: A sterile, enzymatic debriding agent which contains 250 collagenase units per gram of white petrolatum, United States Pharmacopeia (USP).
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
7 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=99 Participants
|
|
Age, Continuous
|
36 years
n=107 Participants
|
37 years
n=206 Participants
|
38 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
2 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
6 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
6 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=107 Participants
|
20 participants
n=206 Participants
|
8 participants
n=99 Participants
|
|
Fitzpatrick Skin Type
Type 2
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
1 Participants
n=99 Participants
|
|
Fitzpatrick Skin Type
Type 3
|
6 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
3 Participants
n=99 Participants
|
|
Fitzpatrick Skin Type
Type 4
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
2 Participants
n=99 Participants
|
|
Fitzpatrick Skin Type
Type 5
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=99 Participants
|
|
Fitzpatrick Skin Type
Type 6
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
2 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 21 Days After TreatmentOutcome will be reported as number of subjects with at least 95% wound healing
Outcome measures
| Measure |
Collagenase Santyl
n=8 Participants
Applied topically (2 mm thickness once daily)
Collagenase Santyl: A sterile, enzymatic debriding agent which contains 250 collagenase units per gram of white petrolatum, United States Pharmacopeia (USP).
|
Bacitracin
n=12 Participants
Applied topically (2 mm thickness) once daily
Bacitracin: One gram is equal to 500 bacitracin units; one unit of bacitracin is equivalent to 0.026 milligrams.
|
|---|---|---|
|
Number of Subjects With at Least 95% Wound Healing
|
6 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: 14 days after treatmentPopulation: number of participants healed after 14 days of treatment
Outcome will be reported as number of subjects with at least 95% wound epithelialization
Outcome measures
| Measure |
Collagenase Santyl
n=8 Participants
Applied topically (2 mm thickness once daily)
Collagenase Santyl: A sterile, enzymatic debriding agent which contains 250 collagenase units per gram of white petrolatum, United States Pharmacopeia (USP).
|
Bacitracin
n=12 Participants
Applied topically (2 mm thickness) once daily
Bacitracin: One gram is equal to 500 bacitracin units; one unit of bacitracin is equivalent to 0.026 milligrams.
|
|---|---|---|
|
Number of Subjects With at Least 95% Wound Healing
|
4 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 90 Days After TreatmentScar appearance will be documented using the Vancouver Scar Scale. It assesses 4 variables: vascularity, height/thickness, pliability, and pigmentation. VSS is derived by adding the score for each variable. Details of VSS is below. The Vancouver Scar Scale Pigmentation (0-2) Normal 0 Hypopigmentation 1 Hyperpigmentation 2 Range of Score: 0-2 with 0 = best outcome, 2 = worst outcome Vascularity (0-3) Normal. 0 Pink 1 Red 2 Purple. 3 Range: 0-3 with 0 = best outcome, 3 = worst outcome Pliability (0-5) Normal 0 Supple 1 Yielding 2 Firm 3 Banding 4 Contracture 5 Range of Score: 0-5, with 0 = best outcome, 5 = worst outcome Height (0-3) Normal (flat) 0 0-2 mm 1 2-5 mm 2 \>5 mm 3 Range of Score 0-3, with 0 = best outcome, 3 = worst outcome Interpretation of Total Score: 0 = best outcome, 13 = worst outcome
Outcome measures
| Measure |
Collagenase Santyl
n=6 Participants
Applied topically (2 mm thickness once daily)
Collagenase Santyl: A sterile, enzymatic debriding agent which contains 250 collagenase units per gram of white petrolatum, United States Pharmacopeia (USP).
|
Bacitracin
n=2 Participants
Applied topically (2 mm thickness) once daily
Bacitracin: One gram is equal to 500 bacitracin units; one unit of bacitracin is equivalent to 0.026 milligrams.
|
|---|---|---|
|
Vancouver Scar Scale
Score of 0
|
2 Participants
|
1 Participants
|
|
Vancouver Scar Scale
Score of 2
|
1 Participants
|
1 Participants
|
|
Vancouver Scar Scale
Score of 4
|
2 Participants
|
0 Participants
|
|
Vancouver Scar Scale
Score of 8
|
1 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up To 90 Days After Treatmenttime to heal in days
Outcome measures
| Measure |
Collagenase Santyl
n=8 Participants
Applied topically (2 mm thickness once daily)
Collagenase Santyl: A sterile, enzymatic debriding agent which contains 250 collagenase units per gram of white petrolatum, United States Pharmacopeia (USP).
|
Bacitracin
n=12 Participants
Applied topically (2 mm thickness) once daily
Bacitracin: One gram is equal to 500 bacitracin units; one unit of bacitracin is equivalent to 0.026 milligrams.
|
|---|---|---|
|
Time to Healing
|
18.67 days
Standard Deviation 6.6
|
28.22 days
Standard Deviation 24.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 90 Days After TreatmentNumber of participants with a burn wound infection cellulitis
Outcome measures
| Measure |
Collagenase Santyl
n=8 Participants
Applied topically (2 mm thickness once daily)
Collagenase Santyl: A sterile, enzymatic debriding agent which contains 250 collagenase units per gram of white petrolatum, United States Pharmacopeia (USP).
|
Bacitracin
n=12 Participants
Applied topically (2 mm thickness) once daily
Bacitracin: One gram is equal to 500 bacitracin units; one unit of bacitracin is equivalent to 0.026 milligrams.
|
|---|---|---|
|
Number of Participants With a Burn Wound Infection
|
0 Participants
|
1 Participants
|
Adverse Events
Collagenase Santyl
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Bacitracin
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Collagenase Santyl
n=8 participants at risk
Applied topically (2 mm thickness once daily)
Collagenase Santyl: A sterile, enzymatic debriding agent which contains 250 collagenase units per gram of white petrolatum, United States Pharmacopeia (USP).
|
Bacitracin
n=12 participants at risk
Applied topically (2 mm thickness) once daily
Bacitracin: One gram is equal to 500 bacitracin units; one unit of bacitracin is equivalent to 0.026 milligrams.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
rash
|
12.5%
1/8 • Number of events 1 • During course of the study, over 90 days
|
25.0%
3/12 • Number of events 3 • During course of the study, over 90 days
|
Additional Information
Suzanne Mitchell, PhD, ARNP, FNP-BC, CWS
The University of Kansas Health System
Phone: 913-588-5000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place