Ecchymosis Clinical Trial
Official title:
The Utility of Peri-operative Arnica Montana for Reduction of Ecchymosis in Rhinoplasty Surgery
Arnica montana is a homeopathic drug that is made in accordance with the official methods of the Homeopathic Pharmacopoeia of the United States (HPUS) and is commonly used by cosmetic surgeons throughout the world, although there is no study proving its benefit after rhinoplasty surgery. The purpose of the research is to see if Arnica montana will reduce the amount of bruising and the intensity of the bruising after surgery. Photographs of the subject's face will be taken and used to analyze bruising after rhinoplasty surgery in subjects who receive Arnica montana and compare them to photographs of subjects who take a placebo (sugar pill).
Subjects will receive either oral arnica montana or placebo without any identifying labels
or markers on the drugs.
During the post-operative period, the patients will be seen back in surgery clinic on
post-operative days 3, 7 and 10. During the first two visits, the subject will receive
routine post-operative care with no difference from patients not enrolled in the study. This
includes routine sets of photographs. The participant will then return for a third
post-operative visit lasting under ten minutes only for study photos using the left and
right "three-quarters" view. Again, the subject will hold a measurement marker so length
measurements can be made, and this marker will be held under the ear to not interfere with
the routine cosmetic analysis of the photographs. The digital photographs will be used to
analyze the bruising for the study. The ratio was calculated by dividing the number of
pixels of bruised area over number of pixels of standard area.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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