Pilot Study to Compare Topical Voriconazole to Placebo as a Pain Reducing Agent

Sponsor
Kenneth Hargreaves (Other)
Overall Status
Withdrawn
CT.gov ID
NCT02689713
Collaborator
San Antonio Military Medical Center (U.S. Fed), U.S. Army Medical Research and Development Command (U.S. Fed)
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Study Details

Study Description

Brief Summary

This study seeks to test if the study drug (voriconazole), when applied topically to a burn wound on the skin will help to reduce pain.

Condition or Disease Intervention/Treatment Phase
  • Drug: Voriconazole (topical)
  • Drug: Topical Sterile Water Placebo Group
Phase 2

Detailed Description

This single-center, prospective, randomized, double-blind, controlled pilot study conducted at San Antonio Military Medical Center will evaluate the effectiveness of topical voriconazole for pain relief at autogenous skin donor sites compared to a topical placebo application. The patients will act as their own control. All participants and investigators in the study will be blinded to the treatment arm utilized on each of the patient's donor sites (voriconazole versus placebo). Patients, who are scheduled for skin grafting and have met the inclusion criteria for this study, will be invited to enroll in the study. Only those patients who have been planned for skin graft sites that are approximately symmetrical in size will be allowed to enroll in the study. The donor site wounds will be studied using a paired design consisting of voriconazole or the placebo applied topically to same-patient matched donor sites. Patients will be queried via the pain assessment tool as to perceived pain at timed intervals. Dialysate samples will be collected via microdialysis probes at matching timed intervals in order to measure levels of oxidized linoleic acid metabolites shown in previous studies to be present in peripheral nerves.

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Supportive Care
Official Title:
Prospective, Randomized, Double-blind Controlled Pilot Study to Compare Topical Voriconazole to Placebo as a Pain Reducing Agent at Skin Donor Sites
Anticipated Study Start Date :
Jun 15, 2018
Actual Primary Completion Date :
Nov 14, 2018
Actual Study Completion Date :
Nov 14, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Topical Voriconazole Study Drug Group

Subjects between 18 and 60 years old who have sustained a burn wound of less than 30% total body surface area, or traumatic wounds requiring skin graft will have the Topical Voriconazole study drug placed on graft site.

Drug: Voriconazole (topical)
The voriconazole (Vfend®-IV 200mg) will be applied topically to one of two skin graft sites at a concentration of 150 micromolar. Dialysates will be collected over 12 hours post-skin graft/voriconazole application for analysis in the lab of OLAM concentrations.
Other Names:
  • Vfend IV 200mg
  • Placebo Comparator: Topical Sterile Water Placebo Group

    Subjects between 18 and 60 years old who have sustained a burn wound of less than 30% total body surface area, or traumatic wounds requiring skin graft will have the Topical Sterile Water Placebo placed on graft site.

    Drug: Topical Sterile Water Placebo Group
    Sterile water will be applied topically to the other of the two skin graft sites. Dialysates will be collected over 12 hours post-skin graft/sterile water application for analysis in the lab of OLAM concentrations.
    Other Names:
  • Sterile Water Placebo
  • Outcome Measures

    Primary Outcome Measures

    1. Pain Levels reported by patient on the Four Point Category Pain Scale at specific timepoints over 72 hours will be compared to pre-operative baseline pain report. [Pre-operatively then over 72 hours post-skin graft procedure (1, 3, 6, 9, 12, 24, 36,48, 60 and 72 hours)]

      Subjects will complete a pre-op pain assessment tool (Four Point Category Pain Scale consisting of 0-3 numeric with corresponding adjectives), then complete the same instrument at 1, 3, 6, 9, 12, 24, 36,48, 60 and 72 hours post-procedure.

    2. Pain Levels reported by the patient on the Heft-Parker Pain Scale at specific timepoints over 72 hours will be compared to pre-operative baseline pain report. [Pre-operatively then over 72 hours post-skin graft (1, 3, 6, 9, 12, 24, 36,48, 60 and 72 hours)]

      Subjects will complete a pre-op pain assessment tool (Heft-Parker Pain Scale - 170mm), then complete the same instrument at 1, 3, 6, 9, 12, 24, 36,48, 60 and 72 hours post-procedure.

    3. Pain Levels reported by the patient on the Visual Analog Pain Scale at specific timepoints over 72 hours compared to pre-operative baseline pain report. [Pre-operatively then over 72 hours post-skin graft (1, 3, 6, 9, 12, 24, 36,48, 60 and 72 hours)]

      Subjects will complete a pre-op pain assessment tool (Visual Analog Pain Scale - 100mm), then complete the same instrument at 1, 3, 6, 9, 12, 24, 36,48, 60 and 72 hours post-procedure.

    4. Cutaneous dialysate levels collected over time to measure baseline vs. timepoint oxidized linoleic acid metabolites (OLAMs) levels. [Over 72 hours post-skin graft (1, 3, 6, 9, 12, 24, 36,48, 60 and 72 hours)]

      Microdialysates will be collected from the CMA-70 probe and CMA-106 pump at 1, 2, 3, 6, 9,12, 24, 36, 48,60, and 72 hours post drug administration [+/- 20 minutes per time interval]. The specific timepoint dialysates levels will be analysed and compared to baseline.

    Secondary Outcome Measures

    1. Skin graft donor site wounds compared for cosmetic healing via photograph at post-op visit [At scheduled post-op visit between 30-45 days post-procedure]

      Digital photographs of the wounds will be taken at the post-op visit scheduled between 30-45 days after the skin graft procedure to assess the cosmetic appearance of the two wound sites.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1.1 Subject must be at least 18 years of age and no older than 60 years of age of either gender and in good general health.

    1.2 Subject has sustained burn wounds of less than 30 percent of the total body surface area, in order to minimize the systemic effects on wound healing and the risk of infection (both of which increase with increasing burn size).

    1.3 Subject has sustained Burn or trauma/orthopedic wounds do not involve the harvesting area.

    1.4 Subject has sustained burn or trauma/orthopedic wounds that, in the judgment of the attending surgeon, require excision and grafting of sufficient extent to justify two donor sites of equal and symmetrical size on non-dependent body surfaces areas. Note: Only two donor sites will be studied, however if the subject requires more than two donor sites, they will not be excluded.

    1.5 The scheduled excision and grafting procedure is the first such operation for the subject during this hospitalization and injury.

    1.6 Subject agrees to participate in follow-up evaluations (Post Op Day 0-3 and one follow up appointment between Post Op day 30-45 for Donor site evaluation and photos of both donor sites.

    Exclusion Criteria:

    2.1 Critical illnesses such as those requiring ventilator support, or having a systemic infection or hemodynamic instability, defined as a mean arterial pressure less than 60 for an extended period of time or requiring vasoactive medications to support blood pressure.

    2.2 Patients unable to accurately communicate pain secondary to medical illness, altered mental status, spinal cord injury, and known current narcotic drug use.

    2.3 Patients unable to make his/her own decision for the informed consent. (Not seeking consent from the legal authorized representative; self consent only).

    2.4 Major acute or chronic medical illnesses that could affect wound healing (e.g. peripheral vascular disease, blood clotting disorder).

    2.6 Cellulitis or other infection of the potential donor sites.

    2.7 Donor site has been previously harvested for grafting.

    2.8 Donor site crosses a joint.

    2.9 Any Corticosteroid use that could interfere with wound healing thus OLAM levels.

    2.10 Subjects with greater than 30% total body surface area burns.

    2.11 Pregnancy or lactation. (Beta HCG pregnancy test completed prior to operative procedure, not part of study) In the event that we have a record of a hysterectomy, no pregnancy test will be done, and the subject will be assumed NOT to be pregnant.

    2.12 Prisoners.

    2.13 Subjects having any contraindications for voriconazole. The contraindications are 1) known hypersensitivity to voriconazole; and 2) Coadministration of terfenadine, astemizole, cisapride, pimozide, quinidine or sirolimus, rifampin, carbamazepine, long acting barbiturates, high dose ritonavir, rifabutin, ergotamine, dihydroergotamine, oral contraceptives or St. John's Wort. A one week washout shall be determined for the above listed medications prior to allowing entry into the study.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 San Antonio Military Medical Center San Antonio Texas United States 78234

    Sponsors and Collaborators

    • Kenneth Hargreaves
    • San Antonio Military Medical Center
    • U.S. Army Medical Research and Development Command

    Investigators

    • Principal Investigator: Christopher E White, MD, Brook Army Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Kenneth Hargreaves, Chair, Dept. of Endodontics, The University of Texas Health Science Center at San Antonio
    ClinicalTrials.gov Identifier:
    NCT02689713
    Other Study ID Numbers:
    • HSC20120196H
    First Posted:
    Feb 24, 2016
    Last Update Posted:
    Dec 17, 2018
    Last Verified:
    Dec 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Kenneth Hargreaves, Chair, Dept. of Endodontics, The University of Texas Health Science Center at San Antonio
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 17, 2018