Open-label Study to Evaluate the Efficacy and Safety of Fespixon Cream for the Treatment of Press… (NCT05317442) | Clinical Trial Compass
TerminatedPhase 4
Open-label Study to Evaluate the Efficacy and Safety of Fespixon Cream for the Treatment of Pressure Injury in Sacrum and Greater Trochanter Wound
Stopped: Study halted prematurely and will not resume.
Taiwan10 participantsStarted 2022-04-06
Plain-language summary
Open-label Study to Evaluate the Efficacy and Safety of Fespixon Cream for the Treatment of Pressure Injury in Sacrum and Greater Trochanter Wound
Who can participate
Age range20 Years – 99 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. At least 20 years old, less than 99 (inclusive) years old, with pressure wounds located in the sacral vertebrae and greater trochanter
✓. NPUAP is classified as stage 2
✓. No active infection, i.e., IDSA level 1
✓. Ulcer area should be ≥4 cm² and ≤25 cm² ( after necessary debridement and at time of enrollment)
✓. If an artificial ostomy is not performed, the distance between the target ulcer and the anus must be greater than 5 cm to prevent contamination
Exclusion criteria
✕. Those who have an allergic reaction to the ingredients of this product, including those who have been allergic to sulfa drugs, Plectranthus amboinicus, Centella asiatica or excipients
✕. Acute infection caused by wound ( WBC \> 12×10³/uL； or C-Reactive protein (CRP) \> 30 mg/dL)
✕. Liver and kidney dysfunction ( defined as \[AST or ALT\] \> 3× the upper limit of normal; serum creatinine \> 3× the upper limit of normal)
✕. Pregnant or lactating women
✕. Infected with human immunodeficiency virus
✕. Body mass index (BMI) less than 18.5 kg/m²
✕. Unable to cooperate with changing of subject's position
What they're measuring
1
Incidence of treatment-related Adverse Events associated with Fespixon cream