Back to resultsThe Utility of Peri-operative Arnica Montana for Reduction of Ecchymosis in Rhinoplasty Surgery
Primary Purpose
Ecchymosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Arnica montana
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Ecchymosis focused on measuring ecchymosis, bruising, rhinoplasty, nose job, arnica, arnica montana
Eligibility Criteria
Inclusion Criteria: Adult patients who are deemed candidates for rhinoplasty surgery at UW Transformations will be eligible to participate in the study.
-
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
Sites / Locations
- University of Wisconsin-Madison
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Arnica Montana
Placebo
Arm Description
The subject will take twelve pills by mouth three times a day over four days.
The subject will take twelve pills by mouth three times a day over four days.
Outcomes
Primary Outcome Measures
Assess Extent of Bruising
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.
Assess Extent of Bruising
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.
Assess Extent of Bruising
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01164644
First Posted
July 15, 2010
Last Updated
April 11, 2017
Sponsor
University of Wisconsin, Madison
1. Study Identification
Unique Protocol Identification Number
NCT01164644
Brief Title
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
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
4. Oversight
Data Monitoring Committee
No
5. 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ecchymosis
Keywords
ecchymosis, bruising, rhinoplasty, nose job, arnica, arnica montana
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arnica Montana
Arm Type
Active Comparator
Arm Description
The subject will take twelve pills by mouth three times a day over four days.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
The subject will take twelve pills by mouth three times a day over four days.
Intervention Type
Drug
Intervention Name(s)
Arnica montana
Intervention Description
Subjects will take twelve pills by mouth three times a day over four days.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Sugar pill
Intervention Description
Subjects will take twelve pills by mouth three times a day over four days.
Primary Outcome Measure Information:
Title
Assess Extent of Bruising
Description
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.
Time Frame
Post-operative day 3
Title
Assess Extent of Bruising
Description
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.
Time Frame
Post-operative day 7
Title
Assess Extent of Bruising
Description
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.
Time Frame
Post-operative day 10
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult patients who are deemed candidates for rhinoplasty surgery at UW Transformations will be eligible to participate in the study.
-
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin C Marcus, MD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin-Madison
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Utility of Peri-operative Arnica Montana for Reduction of Ecchymosis in Rhinoplasty Surgery
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