Impaired Wound Healing, Scarring
Conditions
Keywords
wound healing, scarring, collagenase, Santyl
Brief summary
A study to compare the rate of complete wound closure and quality of resulting scar at 3, 6 and 9 months, between dermatome-induced skin wounds treated with Collagenase Santyl Ointment versus vehicle alone.
Interventions
Dermatome-induced skin wounds treated with drug active. Each subject serves as his own control receiving both treatments in parallel.
DRUGCollagenase Santyl Vehicle
Dermatome-induced skin wounds treated with Vehicle alone. Each subject serves as his own control receiving both treatments in parallel.
Sponsors
Healthpoint
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
1. Provide written informed consent 2. Willing to attend all required study visits
Exclusion criteria
1. Known hypersensitivity to Clostridial collagenase 2. Anticoagulants (blood thinners, including aspirin) within two weeks 3. Congenital skin disorder which affects keratinocytes, elastin, or collagen 4. Any dermatologic disease which may be aggravated or provoked by the wounding procedure 5. Dark skin pigmentation to a degree which is very likely to obscure the assessment of vascularization post-wounding 6. At risk of keloid or hypertrophic scar formation 7. Scars, tattoos or deformities (i.e., contractures) on the inner aspect of the upper arm area where the wound will be placed 8. Any skin disorder which causes delayed healing 9. Disrupted lymphatic drainage of the arm to be studied, or previously diagnosed thoracic outlet syndrome 10. Taking concomitant medications at doses which are known to interfere with healing, such as non-steroidal anti-inflammatory drugs, anti-neoplastic drugs, or immunosuppressive drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to Complete Wound Closure Collagenase Santyl and Vehicle | 21 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Differences in Scar Viscoelasticity Between Wounds Treated With Collagenase Santyl and Its Vehicle | 9 Months | Differences in Scar Viscoelasticity between wounds treated with Collagenase Santyl and its vehicle as measured by Stiffness and Energy Absorption using BTC-2000 measurements. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Rate of Wound Closure Collagenase Santyl vs. Vehicle Dermatome-induced skin wounds treated with drug active (collagenase). Each subject received 2 identical wounds, one on each arm. One arm was treated with Collagenase Santyl, the other with Vehicle. Each subject acted as their own control. | 28 |
| Total | 28 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 2 |
Baseline characteristics
| Characteristic | Rate of Wound Closure Collagenase Santyl vs. Vehicle |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 28 Participants |
| Age Continuous | 37.6 years STANDARD_DEVIATION 8.2 |
| Region of Enrollment United States | 28 participants |
| Sex: Female, Male Female | 18 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 4 / 28 |
| serious Total, serious adverse events | 1 / 28 |
Outcome results
Primary
Time to Complete Wound Closure Collagenase Santyl and Vehicle
Time frame: 21 days
Population: Analysis was performed on all subjects as intent-to-treat (ITT).
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Collagenase Santyl Rate of Wound Closure | Time to Complete Wound Closure Collagenase Santyl and Vehicle | 12.9 Days |
| Vehicle Rate to Complete Wound Healing | Time to Complete Wound Closure Collagenase Santyl and Vehicle | 13.0 Days |
Comparison: Each subject served as their own control, each receiving duplicate dermatome-induced wounds with 1 wound treated with active drug and the other treated with vehicle. Mean time to wound closure was calculated for the wounds treated with drug, the wounds treated with vehicle, and an over-all mean time to wound closurep-value: <0.05Paired-Prentice Wilcoxon (PPW)
Secondary
Differences in Scar Viscoelasticity Between Wounds Treated With Collagenase Santyl and Its Vehicle
Differences in Scar Viscoelasticity between wounds treated with Collagenase Santyl and its vehicle as measured by Stiffness and Energy Absorption using BTC-2000 measurements.
Time frame: 9 Months
Population: Analysis performed on Intent-to-Treat (ITT) population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Collagenase Santyl Rate of Wound Closure | Differences in Scar Viscoelasticity Between Wounds Treated With Collagenase Santyl and Its Vehicle | Stiffness | 184.25 mmHg/mm | Standard Deviation 37.47 |
| Collagenase Santyl Rate of Wound Closure | Differences in Scar Viscoelasticity Between Wounds Treated With Collagenase Santyl and Its Vehicle | Energy Absorption | 72.6 mmHg/mm | Standard Deviation 18.33 |
| Vehicle Rate to Complete Wound Healing | Differences in Scar Viscoelasticity Between Wounds Treated With Collagenase Santyl and Its Vehicle | Energy Absorption | 78.48 mmHg/mm | Standard Deviation 24.96 |
| Vehicle Rate to Complete Wound Healing | Differences in Scar Viscoelasticity Between Wounds Treated With Collagenase Santyl and Its Vehicle | Stiffness | 174.05 mmHg/mm | Standard Deviation 46.51 |
Comparison: Stiffness: Paired t-test and Wilcoxon signed rank test were used for testing any significant differences (Sig. diff.) between the two treatmentsp-value: <0.05t-test, 2 sided
Comparison: Energy Absorption: Paired t-test and Wilcoxon signed rank test were used for testing any significant differences (Sig. diff.) between the two treatmentsp-value: <0.05t-test, 2 sided