Using Santyl or Bacitracin on Second Degree Burns

NCT ID: NCT01516463

Last Updated: 2012-05-16

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2013-12-31

Brief Summary

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

Conditions

Burn, Partial Thickness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Collagenase Santyl

Group Type: ACTIVE_COMPARATOR

Collagenase Santyl

Intervention Type: DRUG

Applied topically (2 mm thickness once daily)

Bacitracin

Group Type: SHAM_COMPARATOR

Bacitracin

Intervention Type: BIOLOGICAL

Applied topically (2 mm thickness) once daily

Interventions

Collagenase Santyl

Applied topically (2 mm thickness once daily)

Intervention Type: DRUG

Bacitracin

Applied topically (2 mm thickness) once daily

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Healthpoint

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Herbert B Slade, MD

Role: STUDY_CHAIR

Healthpoint

Dhaval Bhavsar, MD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Other Identifiers

017-101-09-031

Identifier Type: -

Identifier Source: org_study_id