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

• Status: Withdrawn
• Trial end date: 2018-11-14
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kenneth Hargreaves
• Collaborators: San Antonio Military Medical Center; U.S. Army Medical Research and Development Command; U.S. Army Medical Research and Materiel Command
• Treatments: Voriconazole

Criteria

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.