Comparison of Collagenase Santyl Ointment With Antibiotic Ointment in the Outpatient Care of Minor Partial Thickness Burns
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|ClinicalTrials.gov Identifier: NCT02673229|
Recruitment Status : Recruiting
First Posted : February 3, 2016
Last Update Posted : July 22, 2019
|Condition or disease||Intervention/treatment||Phase|
|Burn, Partial Thickness||Drug: Collagenase Santyl Drug: Bacitracin||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparison of Collagenase Santyl Ointment With Antibiotic Ointment in the Outpatient Care of Minor Partial Thickness Burns|
|Study Start Date :||January 2014|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||December 2021|
Active Comparator: Collagenase Santyl
Applied topically (2 mm thickness once daily)
Drug: Collagenase Santyl
A sterile, enzymatic debriding agent which contains 250 collagenase units per gram of white petrolatum, United States Pharmacopeia (USP).
Sham Comparator: Bacitracin
Applied topically (2 mm thickness) once daily
One gram is equal to 500 bacitracin units; one unit of bacitracin is equivalent to 0.026 milligrams.
Other Name: Bacitracin Zinc Ointment
- Proportion Healed [ Time Frame: 21 Days After Treatment ]Outcome will be reported as percent of wound epithelialization.
- Scar Appearance using the Vancouver Scar Scale [ Time Frame: 90 Days After Treatment ]Scar appearance will be documented using the Vancouver Scar Scale. It assesses 4 variables: vascularity, height/thickness, pliability, and pigmentation.
- Time to Healing [ Time Frame: Up To 90 Days After Treatment ]
- Incidence of Burn Wound Infection [ Time Frame: Up to 90 Days After Treatment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02673229
|Contact: Jessica Reynolds, BSNfirstname.lastname@example.org|
|United States, Kansas|
|University of Kansas Medical Center||Recruiting|
|Kansas City, Kansas, United States, 66160|
|Principal Investigator:||Dhaval Bhavsar, MD||University of Kansas Medical Center|