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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01516463
Other study ID # 017-101-09-031
Secondary ID
Status Withdrawn
Phase Phase 4
First received January 19, 2012
Last updated May 15, 2012
Start date March 2012
Est. completion date December 2013

Study information

Verified date May 2012
Source Healthpoint
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date December 2013
Est. primary completion date June 2013
Accepts healthy volunteers No
Gender Both
Age group 2 Years to 75 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Collagenase Santyl
Applied topically (2 mm thickness once daily)
Biological:
Bacitracin
Applied topically (2 mm thickness) once daily

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Healthpoint

Outcome

Type Measure Description Time frame Safety issue
Primary Scar Appearance 90 Days No
Secondary Proportion healed at two weeks 2 weeks after initiation of treatment No
See also
  Status Clinical Trial Phase
Recruiting NCT02673229 - Comparison of Collagenase Santyl Ointment With Antibiotic Ointment in the Outpatient Care of Minor Partial Thickness Burns Phase 4
Completed NCT04079998 - Procellera® Compared to Standard of Care Treatment in Mitigating Biofilm Formation in Acute Trauma and Burn Wounds N/A
Completed NCT05148390 - Study to Examine Clinical Performance and Safety of Cutimed® Gelling Fiber in Routine Clinical Practice