Clinical trial NCT01164644: The Utility of Peri-operative Arnica Montana for Reduction of Ecchymosis in Rhinoplasty Surgery
Official title: The Utility of Peri-operative Arnica Montana for Reduction of Ecchymosis in Rhinoplasty Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ecchymosis
Keywords: ecchymosis
bruising
rhinoplasty
nose job
arnica
arnica montana
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2010-07-16
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria: Adult patients who are deemed candidates for rhinoplasty surgery at UW Transformations will be eligible to participate in the study.

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Exclusion Criteria:

* Patients who are prisoners
* Patients who are pregnant and breast-feeding women
* Patients taking anti-coagulants (such as blood thinners), anti-platelet drugs (such as NSAIDS), or other homeopathic remedies during the peri-operative period
* Patients with a bruising or bleeding disorder
* Patients who take oral corticosteroid therapy
* Patients who suffer from severe liver or kidney disease
* Patients with malignancy, infection, immunodeficiency, metabolic syndrome, infectious or inflammatory gastrointestinal disease
* Patients with oral or contact allergies to Arnica montana or to any other member of the Asteraceae family of plants such as ragweed, chrysanthemums, marigolds, and daisies

Primary outcomes:
measure: Assess Extent of Bruising
timeFrame: Post-operative day 3
measure: Assess Extent of Bruising
timeFrame: Post-operative day 7
measure: Assess Extent of Bruising
timeFrame: Post-operative day 10
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin-Madison
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Benjamin C Marcus, MD
role: PRINCIPAL_INVESTIGATOR
References: