Using Santyl or Bacitracin on Second Degree Burns

Comparison of Collagenase Santyl® Ointment With Antibiotic Ointment in the Outpatient Care of Minor Partial Thickness Burns

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 every 1-3 months for up to 1 year. At these visits, the appearance of the scar will be evaluated

Study Overview

• Status: Withdrawn
• Conditions: Burn, Partial Thickness
• Intervention / Treatment: Drug: Collagenase Santyl; Biological: Bacitracin

• Study Type: Interventional
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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 IRB.
• Age 2 - 75 yrs, either sex, any race.
• Have one or more acute burns which:
• • are thermal, chemical or electrical in etiology
• • in aggregate cover <10% TBSA
• • are each equal to or less than 72 hrs old
• • are each no more than deep partial thickness (2nd degree)
• • are not visibly infected
• Able to take in oral fluids.
• Able to comply with the requirement for daily dressing changes, or have a caretaker who is able to comply.
• Willing to make all required study visits.

Exclusion Criteria:

• Contraindications or hypersensitivity to the use of the test article or their components (e.g., known hypersensitivity to bacitracin).
• Embedded foreign bodies in the burn wound which cannot be immediately removed.
• The burned tissue includes or is within 1 cm of the eye or genitalia.
• Severe perioral burns.
• Airway involvement or aspiration of hot liquids.
• Suspicion of physical abuse.
• Burn wound requires a skin graft.
• Outpatient management of the burn wound is not appropriate.
• Participation in another investigational clinical study within thirty (30) days of the Screening Visit.
• 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.
• The Medical Monitor and / or Investigator may declare any subject ineligible for a valid medical reason.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Collagenase Santyl	Drug: Collagenase Santyl; Applied topically (2 mm thickness once daily)
Sham Comparator: Bacitracin	Biological: Bacitracin; Applied topically (2 mm thickness) once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Scar Appearance	90 Days

Secondary Outcome Measures

Outcome Measure	Time Frame
Proportion healed at two weeks	2 weeks after initiation of treatment

Collaborators and Investigators

• Sponsor: Healthpoint
• Investigators: Principal Investigator: Dhaval Bhavsar, MD, University of Kansas Medical Center

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Anticipated): June 1, 2013
• Study Completion (Anticipated): December 1, 2013

Study Registration Dates

• First Submitted: January 19, 2012
• First Submitted That Met QC Criteria: January 23, 2012
• First Posted (Estimate): January 24, 2012

Study Record Updates

• Last Update Posted (Estimate): May 16, 2012
• Last Update Submitted That Met QC Criteria: May 15, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Keywords: scar; University of Kansas Medical Center; burn; partial thickness burn; second degree burn; minor burn; Santyl; Bacitracin; outpatient burn center; scar appearance; Kansas City; KUMC
• Additional Relevant MeSH Terms: Wounds and Injuries; Burns; Anti-Infective Agents, Local; Anti-Infective Agents; Anti-Bacterial Agents; Bacitracin
• Other Study ID Numbers: 017-101-09-031