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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
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.
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.
San Antonio Military Medical Center
San Antonio, Texas, United States
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.
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.
Time frame: Pre-operatively then over 72 hours post-skin graft procedure (1, 3, 6, 9, 12, 24, 36,48, 60 and 72 hours)
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.
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.
Time frame: Pre-operatively then over 72 hours post-skin graft (1, 3, 6, 9, 12, 24, 36,48, 60 and 72 hours)
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.
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.
Time frame: Pre-operatively then over 72 hours post-skin graft (1, 3, 6, 9, 12, 24, 36,48, 60 and 72 hours)
Cutaneous dialysate levels collected over time to measure baseline vs. timepoint oxidized linoleic acid metabolites (OLAMs) levels.
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.
Time frame: Over 72 hours post-skin graft (1, 3, 6, 9, 12, 24, 36,48, 60 and 72 hours)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Skin graft donor site wounds compared for cosmetic healing via photograph at post-op visit
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.
Time frame: At scheduled post-op visit between 30-45 days post-procedure