Clinical trial NCT02673229: Comparison of Collagenase With Antibiotic Ointment of Minor Partial Thickness Burns
Official title: Comparison of Collagenase Santyl Ointment With Antibiotic Ointment in the Outpatient Care of Minor Partial Thickness Burns
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Burn, Partial Thickness
Keywords: Santyl
Burn
Partial Thickness Burn
Second Degree Burn
Minor Burn Bacitracin
Scar Appearance
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2016-02-03
Enrollment: 20
Sex: ALL
Minimum age (years): 2
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Subjects With at Least 95% Wound Healing
timeFrame: 21 Days After Treatment
measure: Number of Subjects With at Least 95% Wound Healing
timeFrame: 14 days after treatment
Secondary outcomes:
measure: Vancouver Scar Scale
timeFrame: 90 Days After Treatment
Other outcomes:
measure: Time to Healing
timeFrame: Up To 90 Days After Treatment
measure: Number of Participants With a Burn Wound Infection
timeFrame: Up to 90 Days After Treatment
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Dhaval Bhavsar, MD
role: PRINCIPAL_INVESTIGATOR
References: