Burn, Partial Thickness
Conditions
Keywords
Santyl, Burn, Partial Thickness Burn, Second Degree Burn, Minor Burn Bacitracin, Scar Appearance
Brief summary
By doing this study, researchers hope to learn if applying Santyl to the burn during the healing process affects the appearance of the resulting scar.
Detailed description
Subjects who have minor, second degree burns may be enrolled in this study. Subjects will receive either Santyl ointment or bacitracin ointment to apply to the burn until it heals. Bandages will be used to keep the burn covered while it heals. Second degree burns generally leave a scar. Once the burn heals, lotion and an appropriate bandage will be used to try to minimize the appearance of a scar. The study hypothesis is that burns treated with Santyl will have a better scar appearance than burns treated with bacitracin. Subjects enrolled in this study will make once a week visits to the University of Kansas Medical Center outpatient burn clinic until the burn heals. The burn will be assessed for healing at these visits. Once healed, visits to the clinic will be at 60 & 180 days, up to 6 months. At these visits, the appearance of the scar will be evaluated. This study was originally funded by Smith and Nephew, but Smith and Nephew is no longer providing support for the study.
Interventions
A sterile, enzymatic debriding agent which contains 250 collagenase units per gram of white petrolatum, United States Pharmacopeia (USP).
DRUGBacitracin
One gram is equal to 500 bacitracin units; one unit of bacitracin is equivalent to 0.026 milligrams.
Sponsors
University of Kansas Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Provide written informed consent, which will consist of reading, signing, and dating the informed consent document after the Investigator, sub-Investigator or other designated study staff member has explained the study procedures, risks, and contact information. For subjects not able to provide informed consent (e.g., minors), a parent or legally authorized representative must provide consent. Assent must be provided as required by the Institutional Review Board (IRB). 2. Have one or more acute burns which: 1. are thermal, chemical or electrical in etiology 2. in aggregate cover \<10% total body surface area (TBSA) 3. are each equal to or less than 72 hrs old 4. are each no more than deep partial thickness (2nd degree) 5. are not visibly infected 3. Able to take in oral fluids. 4. Able to comply with the requirement for daily dressing changes, or have a caretaker who is able to comply. 5. Willing to make all required study visits.
Exclusion criteria
1. Contraindications or hypersensitivity to the use of the test article or their components (e.g., known hypersensitivity to bacitracin). 2. Embedded foreign bodies in the burn wound which cannot be immediately removed. 3. The burned tissue includes or is within 1 cm of the eye or genitalia. 4. Severe perioral burns. 5. Airway involvement or aspiration of hot liquids. 6. Suspicion of physical abuse. 7. Burn wound requires a skin graft. 8. Outpatient management of the burn wound is not appropriate. 9. Participation in another investigational clinical study within thirty (30) days of the Screening Visit. 10. The Investigator may declare any subject ineligible for a valid medical reason. Current or recent (\< 6 months) history of severe, unstable, or uncontrolled neurological, cardiovascular, gastrointestinal, hematological, hepatic, and/or renal disease or evidence of other diseases based upon a review of medical history that, in the opinion of the Investigator, would preclude safe subject participation in the study. 11. Test articles are cost-prohibitive for subjects
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With at Least 95% Wound Healing | 21 Days After Treatment | Outcome will be reported as number of subjects with at least 95% wound healing |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vancouver Scar Scale | 90 Days After Treatment | Scar 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Time to Healing | Up To 90 Days After Treatment | time to heal in days |
| Number of Participants With a Burn Wound Infection | Up to 90 Days After Treatment | Number of participants with a burn wound infection cellulitis |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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). | 8 |
| 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. | 12 |
| Total | 20 |
Baseline characteristics
| Characteristic | Collagenase Santyl | Bacitracin | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants | 12 Participants | 19 Participants |
| Age, Continuous | 38 years | 36 years | 37 years |
| Fitzpatrick Skin Type Type 2 | 1 Participants | 2 Participants | 3 Participants |
| Fitzpatrick Skin Type Type 3 | 3 Participants | 6 Participants | 9 Participants |
| Fitzpatrick Skin Type Type 4 | 2 Participants | 3 Participants | 5 Participants |
| Fitzpatrick Skin Type Type 5 | 0 Participants | 0 Participants | 0 Participants |
| Fitzpatrick Skin Type Type 6 | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 6 Participants | 10 Participants | 16 Participants |
| Region of Enrollment United States | 8 participants | 12 participants | 20 participants |
| Sex: Female, Male Female | 2 Participants | 3 Participants | 5 Participants |
| Sex: Female, Male Male | 6 Participants | 9 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 12 |
| other Total, other adverse events | 1 / 8 | 3 / 12 |
| serious Total, serious adverse events | 0 / 8 | 0 / 12 |
Outcome results
Primary
Number of Subjects With at Least 95% Wound Healing
Outcome will be reported as number of subjects with at least 95% wound healing
Time frame: 21 Days After Treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Collagenase Santyl | Number of Subjects With at Least 95% Wound Healing | 6 Participants |
| Bacitracin | Number of Subjects With at Least 95% Wound Healing | 7 Participants |
Primary
Number of Subjects With at Least 95% Wound Healing
Outcome will be reported as number of subjects with at least 95% wound epithelialization
Time frame: 14 days after treatment
Population: number of participants healed after 14 days of treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Collagenase Santyl | Number of Subjects With at Least 95% Wound Healing | 4 Participants |
| Bacitracin | Number of Subjects With at Least 95% Wound Healing | 5 Participants |
Secondary
Vancouver Scar Scale
Scar 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
Time frame: 90 Days After Treatment
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Collagenase Santyl | Vancouver Scar Scale | Score of 0 | 2 Participants |
| Collagenase Santyl | Vancouver Scar Scale | Score of 2 | 1 Participants |
| Collagenase Santyl | Vancouver Scar Scale | Score of 4 | 2 Participants |
| Collagenase Santyl | Vancouver Scar Scale | Score of 8 | 1 Participants |
| Bacitracin | Vancouver Scar Scale | Score of 8 | 0 Participants |
| Bacitracin | Vancouver Scar Scale | Score of 0 | 1 Participants |
| Bacitracin | Vancouver Scar Scale | Score of 4 | 0 Participants |
| Bacitracin | Vancouver Scar Scale | Score of 2 | 1 Participants |
Other Pre-specified
Number of Participants With a Burn Wound Infection
Number of participants with a burn wound infection cellulitis
Time frame: Up to 90 Days After Treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Collagenase Santyl | Number of Participants With a Burn Wound Infection | 0 Participants |
| Bacitracin | Number of Participants With a Burn Wound Infection | 1 Participants |
Other Pre-specified
Time to Healing
time to heal in days
Time frame: Up To 90 Days After Treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Collagenase Santyl | Time to Healing | 18.67 days | Standard Deviation 6.6 |
| Bacitracin | Time to Healing | 28.22 days | Standard Deviation 24.5 |