Comparison of Collagenase With Antibiotic Ointment of Minor Partial Thickness Burns

NCT02673229 | Terminated Phase 4 Results

• 1 other identifier: 13663
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Burn, Partial Thickness

Keywords

Santyl; Burn; Partial Thickness Burn; Second Degree Burn; Minor Burn Bacitracin; Scar Appearance

Outcome Measures

Primary Outcomes (2)

• Number of Subjects With at Least 95% Wound Healing

  Outcome will be reported as number of subjects with at least 95% wound healing

  21 Days After Treatment

• Number of Subjects With at Least 95% Wound Healing

  Outcome will be reported as number of subjects with at least 95% wound epithelialization

  14 days after treatment

Secondary Outcomes (1)

• Vancouver Scar Scale

  90 Days After Treatment

Other Outcomes (2)

• Time to Healing

  Up To 90 Days After Treatment

• Number of Participants With a Burn Wound Infection

  Up to 90 Days After Treatment

Study Arms (2)

Collagenase Santyl

ACTIVE COMPARATOR

Applied topically (2 mm thickness once daily)

Drug: Collagenase Santyl

Bacitracin

SHAM COMPARATOR

Applied topically (2 mm thickness) once daily

Drug: Bacitracin

Interventions

Collagenase Santyl DRUG

A sterile, enzymatic debriding agent which contains 250 collagenase units per gram of white petrolatum, United States Pharmacopeia (USP).

Collagenase Santyl

Bacitracin DRUG

One gram is equal to 500 bacitracin units; one unit of bacitracin is equivalent to 0.026 milligrams.

Also known as: Bacitracin Zinc Ointment

Bacitracin

Eligibility Criteria

• Age: 2 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• Have one or more acute burns which:
• are thermal, chemical or electrical in etiology
• in aggregate cover \<10% total body surface area (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.

You may not qualify if:

• 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.
• 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.
• Test articles are cost-prohibitive for subjects

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Related Links

• Initial study registration by study agent manufacturer before the study was modified and taken over by a new sponsor

MeSH Terms

Conditions

Burns

Interventions

Bacitracin

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Suzanne Mitchell, PhD, ARNP, FNP-BC, CWS
• Organization: The University of Kansas Health System

smitchell3@kumc.edu

913-588-5000

Study Officials

• Dhaval Bhavsar, MD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 1, 2016
• First Posted: February 3, 2016
• Study Start: September 30, 2013
• Primary Completion: December 27, 2018
• Study Completion: March 30, 2020
• Last Updated: July 10, 2024
• Results First Posted: July 10, 2024

Record last verified: 2024-07

Locations

US (1)