The Utility of Peri-operative Arnica Montana for Reduction of Ecchymosis in Rhinoplasty Surgery

• ClinicalTrials.gov Identifier: NCT01164644
• Recruitment Status: Completed
• First Posted: July 16, 2010
• Results First Posted: May 3, 2013
• Last Update Posted: May 17, 2017
• Sponsor: University of Wisconsin, Madison
• Information provided by (Responsible Party): University of Wisconsin, Madison

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Ecchymosis	Drug: Arnica montana; Drug: Placebo	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 28 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: The Utility of Peri-operative Arnica Montana for Reduction of Ecchymosis in Rhinoplasty Surgery
• Study Start Date: June 2010
• Actual Primary Completion Date: December 2012
• Actual Study Completion Date: December 2012

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Arnica Montana; The subject will take twelve pills by mouth three times a day over four days.	Drug: Arnica montana; Subjects will take twelve pills by mouth three times a day over four days.
Placebo Comparator: Placebo; The subject will take twelve pills by mouth three times a day over four days.	Drug: Placebo; Subjects will take twelve pills by mouth three times a day over four days.; Other Name: Sugar pill

Outcome Measures

Primary Outcome Measures :

1. Assess Extent of Bruising [ Time Frame: Post-operative day 3 ]
   Primary outcome measure will be to measure the extent of bruising in based on a ratio of pixels on post-operative day number three. Every subject held a card in front of their face with a specific size marker. The square area of this marker was known and used to measure the number of pixels in this marker with Photoshop and compare it to the known area. Next the area of bruising was measured in number of pixels. Therefore for every photograph a standardized ratio of pixels was known because of the marker. The ratio was calculated by dividing the number of pixels of bruised area over number of pixels of standard area.
2. Assess Extent of Bruising [ Time Frame: Post-operative day 7 ]
   Primary outcome measure will be to measure the extent of bruising based on a ratio of pixels on post-operative day number seven. Every subject held a card in front of their face with a specific size marker. The square area of this marker was known and used to measure the number of pixels in this marker with Photoshop and compare it to the known area. Next the area of bruising was measured in number of pixels. Therefore for every photograph a standardized ratio of pixels was known because of the marker.
3. Assess Extent of Bruising [ Time Frame: Post-operative day 10 ]
   Primary outcome measure will be to measure the extent of bruising based on a ratio of pixels on post-operative day number ten. Every subject held a card in front of their face with a specific size marker. The square area of this marker was known and used to measure the number of pixels in this marker with Photoshop and compare it to the known area. Next the area of bruising was measured in number of pixels. Therefore for every photograph a standardized ratio of pixels was known because of the marker.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 89 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Wisconsin

University of Wisconsin-Madison

Madison, Wisconsin, United States, 53792

Sponsors and Collaborators

University of Wisconsin, Madison

Investigators

• Principal Investigator: Benjamin C Marcus, MD; University of Wisconsin, Madison

More Information

• Responsible Party: University of Wisconsin, Madison
• ClinicalTrials.gov Identifier: NCT01164644
• Other Study ID Numbers: H-2010-0065
• First Posted: July 16, 2010
• Results First Posted: May 3, 2013
• Last Update Posted: May 17, 2017
• Last Verified: April 2017

Keywords provided by University of Wisconsin, Madison:

ecchymosis; bruising; rhinoplasty; nose job; arnica; arnica montana

Additional relevant MeSH terms:

Ecchymosis; Blood Coagulation Disorders; Hematologic Diseases; Hemorrhage; Pathologic Processes; Skin Manifestations