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

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ClinicalTrials.gov Identifier: NCT02673229
Recruitment Status : Recruiting
First Posted : February 3, 2016
Last Update Posted : July 22, 2019
Sponsor:
Information provided by (Responsible Party):
Dhaval Bhavsar, University of Kansas Medical Center

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.

Condition or disease Intervention/treatment Phase
Burn, Partial Thickness Drug: Collagenase Santyl Drug: Bacitracin Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Collagenase Santyl Ointment With Antibiotic Ointment in the Outpatient Care of Minor Partial Thickness Burns
Study Start Date : January 2014
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns

Arm Intervention/treatment
Active Comparator: Collagenase Santyl
Applied topically (2 mm thickness once daily)
Drug: Collagenase Santyl
A sterile, enzymatic debriding agent which contains 250 collagenase units per gram of white petrolatum, United States Pharmacopeia (USP).

Sham Comparator: Bacitracin
Applied topically (2 mm thickness) once daily
Drug: Bacitracin
One gram is equal to 500 bacitracin units; one unit of bacitracin is equivalent to 0.026 milligrams.
Other Name: Bacitracin Zinc Ointment




Primary Outcome Measures :
  1. Proportion Healed [ Time Frame: 21 Days After Treatment ]
    Outcome will be reported as percent of wound epithelialization.


Secondary Outcome Measures :
  1. Scar Appearance using the Vancouver Scar Scale [ Time Frame: 90 Days After Treatment ]
    Scar appearance will be documented using the Vancouver Scar Scale. It assesses 4 variables: vascularity, height/thickness, pliability, and pigmentation.


Other Outcome Measures:
  1. Time to Healing [ Time Frame: Up To 90 Days After Treatment ]
  2. Incidence of Burn Wound Infection [ Time Frame: Up to 90 Days After Treatment ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   2 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02673229


Contacts
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Contact: Jessica Reynolds, BSN 913-588-0044 jreynolds11@kumc.edu

Locations
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United States, Kansas
University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
University of Kansas Medical Center
Investigators
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Principal Investigator: Dhaval Bhavsar, MD University of Kansas Medical Center
Additional Information:
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Responsible Party: Dhaval Bhavsar, Assistant Professor, University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT02673229    
Other Study ID Numbers: 13663
First Posted: February 3, 2016    Key Record Dates
Last Update Posted: July 22, 2019
Last Verified: July 2019
Keywords provided by Dhaval Bhavsar, University of Kansas Medical Center:
Santyl
Burn
Partial Thickness Burn
Second Degree Burn
Minor Burn Bacitracin
Scar Appearance
Additional relevant MeSH terms:
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Burns
Wounds and Injuries
Bacitracin
Anti-Infective Agents, Local
Anti-Infective Agents
Anti-Bacterial Agents