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Clinical Assessment of Protopic® Ointment in Deep Partial-Thickness Burns

Primary Purpose

Burn Injury

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Tacrolimus ointment
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burn Injury

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Provision of signed and dated informed consent form by the subject or Legally Authorized Representative. Stated willingness to comply with all study procedures and availability for the duration of the study. Male or female aged 50 to 75 at time of screening visit. For females of reproductive potential, confirmed negative urine pregnancy test at enrollment. Presence of deep partial-thickness burns to one or both dorsal hands (burns may be present on other areas of the body, so long as all regions combined are ≤ 5% Total Body Surface Area [TBSA], using the Browder and Lund Chart). Thermal burn (caused by fire, hot objects, steam or hot liquids [scalding]) etiology, located on one or both dorsal hands. Ability to implement treatment within 24-48 hours days of the initial burn. Exclusion Criteria: Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study, if applicable. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data. Allergy or hypersensitivity to tacrolimus or other components of the ointment (per subject report) or personal preference. Allergy or hypersensitivity to bacitracin and/or any of its drug formulation components. Patients with known hypersensitivity to neomycin may also be sensitive to bacitracin. Subject is incarcerated. Friction, chemical or electric burn etiology. Immunosuppression, as determined by the Principal Investigator. Presence of a local and/or systemic infection that, in the Investigator's opinion, requires aggressive treatment which would warrant exclusion from participating in this study. Subject is unwilling or unable to follow study related procedures and/or follow-up visits. Prior treatment to the burn wound(s) on the hand(s) considered for this trial with another product (treatment failure). Subject report of previous participation in another interventional burn wound study within 60 days prior to the Screening Visit. Subject report of concurrent participation in another clinical trial that involves an investigational drug or device that would interfere with this study. The subject has any physical or psychiatric condition that in the Investigator's opinion would warrant exclusion from the study or prevent the subject from completing the study.

Sites / Locations

  • Vanderbilt University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

No Intervention

Arm Label

Tacrolimus Ointment 0.03% with hydrocolloid dressing

Bacitracin ointment

Hydrocolloid dressing

Arm Description

Standard out-patient wound cleaning followed by application of tacrolimus ointment over the burn and hydrocolloid dressing on the treated area.

Standard out-patient wound cleaning followed by application of bacitracin ointment over the burn and hydrocolloid dressing on the treated area.

Standard out-patient wound cleaning followed by application of hydrocolloid dressing on the burned area.

Outcomes

Primary Outcome Measures

Time to complete wound healing
Clinical burn wound assessment

Secondary Outcome Measures

Full Information

First Posted
May 3, 2023
Last Updated
September 7, 2023
Sponsor
Vanderbilt University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05856994
Brief Title
Clinical Assessment of Protopic® Ointment in Deep Partial-Thickness Burns
Official Title
Clinical Assessment of Protopic® Ointment in Deep Partial-Thickness Burns
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2023 (Actual)
Primary Completion Date
December 1, 2024 (Anticipated)
Study Completion Date
June 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
There is currently no standard treatment to prevent burn depth conversion in partial-thickness burns. Conversion into deeper wounds is associated with higher complications and morbidity. The most common theory attributes this depth conversion to the prolonged inflammatory response that occurs after burn injury. Therefore, the investigators propose testing the safety and efficacy of tacrolimus ointment (an immunosuppressive agent) in patients with deep partial-thickness burns.
Detailed Description
Patients who sustain burn injuries are some of the most complex patients to care for, often requiring a multidisciplinary team of providers specialized in burn pathophysiology. While many facets of burn care must be accounted for including fluid management, nutrition, respiratory status, immunologic and cardiovascular function, innovation in the treatment for deep partial thickness burns is of paramount importance. Burn depth conversion is a phenomenon where superficial partial-thickness burns spontaneously convert into deep partial-thickness or full-thickness burns, which are associated with higher complications and morbidity. The most common theory attributes this depth conversion to the prolonged inflammatory response that occurs after burn injury. Excess inflammation worsens the injury through various mechanisms, including cytokine production, delayed inflammatory cell apoptosis, and reactive oxidative species production. Protopic® (tacrolimus) Ointment is a macrolide immunosuppressant and a calcineurin inhibitor. Tacrolimus inhibits T-lymphocyte activation, a key cell in the body's immune response. A prolonged inflammatory response is theorized to contribute to a worse recovery outcome in partial- to full-thickness burns. Therefore, tacrolimus possesses properties that could slow the acute inflammatory response and potentially improve clinical outcomes in deep partial-thickness burns. There has yet to be a clinical study to investigate the use of tacrolimus in burn treatment. However, our group recently published an animal study that found a significant reduction in burn depth using tacrolimus topically (White-Dzuro et al. Burns 2022). This study is a randomized clinical trial of the usage of tacrolimus ointment for the treatment of deep partial-thickness burns with comprehensive assessments of healing and functional outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burn Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tacrolimus Ointment 0.03% with hydrocolloid dressing
Arm Type
Experimental
Arm Description
Standard out-patient wound cleaning followed by application of tacrolimus ointment over the burn and hydrocolloid dressing on the treated area.
Arm Title
Bacitracin ointment
Arm Type
No Intervention
Arm Description
Standard out-patient wound cleaning followed by application of bacitracin ointment over the burn and hydrocolloid dressing on the treated area.
Arm Title
Hydrocolloid dressing
Arm Type
No Intervention
Arm Description
Standard out-patient wound cleaning followed by application of hydrocolloid dressing on the burned area.
Intervention Type
Drug
Intervention Name(s)
Tacrolimus ointment
Other Intervention Name(s)
Protopic® ointment
Intervention Description
For the active comparator group, the wound(s) will be cleaned and bacitracin ointment will be applied to the wound. External dressings on all treated wounds will be placed based on the current standard of care. For the control group, the wound(s) will be cleaned and a hydrocolloid Dressing will be affixed to the burn and treated area. For the treatment group, the wound(s) will be cleaned and tacrolimus (0.03%) ointment will be applied over the burn. Hydrocolloid Dressing will be affixed to the burn and treated area. External dressings on all treated wounds will be placed based on the current standard of care.
Primary Outcome Measure Information:
Title
Time to complete wound healing
Description
Clinical burn wound assessment
Time Frame
21 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Provision of signed and dated informed consent form by the subject or Legally Authorized Representative. Stated willingness to comply with all study procedures and availability for the duration of the study. Male or female aged 50 to 75 at time of screening visit. For females of reproductive potential, confirmed negative urine pregnancy test at enrollment. Presence of deep partial-thickness burns to one or both dorsal hands (burns may be present on other areas of the body, so long as all regions combined are ≤ 5% Total Body Surface Area [TBSA], using the Browder and Lund Chart). Thermal burn (caused by fire, hot objects, steam or hot liquids [scalding]) etiology, located on one or both dorsal hands. Ability to implement treatment within 24-48 hours days of the initial burn. Exclusion Criteria: Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study, if applicable. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data. Allergy or hypersensitivity to tacrolimus or other components of the ointment (per subject report) or personal preference. Allergy or hypersensitivity to bacitracin and/or any of its drug formulation components. Patients with known hypersensitivity to neomycin may also be sensitive to bacitracin. Subject is incarcerated. Friction, chemical or electric burn etiology. Immunosuppression, as determined by the Principal Investigator. Presence of a local and/or systemic infection that, in the Investigator's opinion, requires aggressive treatment which would warrant exclusion from participating in this study. Subject is unwilling or unable to follow study related procedures and/or follow-up visits. Prior treatment to the burn wound(s) on the hand(s) considered for this trial with another product (treatment failure). Subject report of previous participation in another interventional burn wound study within 60 days prior to the Screening Visit. Subject report of concurrent participation in another clinical trial that involves an investigational drug or device that would interfere with this study. The subject has any physical or psychiatric condition that in the Investigator's opinion would warrant exclusion from the study or prevent the subject from completing the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wesley Thayer, MD, PhD
Phone
6159360160
Email
wesley.thayer@vumc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Julia Yao, BSN
Phone
6153438426
Email
jun.yao@vumc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wesley Thayer, MD, PhD
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

Clinical Assessment of Protopic® Ointment in Deep Partial-Thickness Burns

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