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

• Sponsor: University of Wisconsin, Madison (Other)
• Overall Status: Completed
• CT.gov ID: NCT01164644
• Collaborator: (none)
• Enrollment: 28
• Location: 1
• Arms: 2
• Duration (Months): 30
• Patients Per Site Per Month: 0.9

Study Details

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	N/A

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
• 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: Jun 1, 2010
• Actual Primary Completion Date: Dec 1, 2012
• Actual Study Completion Date: Dec 1, 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 Names: Sugar pill

Outcome Measures

Primary Outcome Measures

1. Assess Extent of Bruising [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 [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 [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

Criteria

• Ages Eligible for Study: 18 Years to 89 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Wisconsin, Madison
• ClinicalTrials.gov Identifier: NCT01164644
• Other Study ID Numbers: H-2010-0065
• First Posted: Jul 16, 2010
• Last Update Posted: May 17, 2017
• Last Verified: Apr 1, 2017

• Keywords provided by University of Wisconsin, Madison: ecchymosis; bruising; rhinoplasty; nose job; arnica; arnica montana
• Additional relevant MeSH terms: Ecchymosis

Study Results

Participant Flow

Recruitment Details	Adult patients scheduled for rhinoplasty surgery with nasal bone osteotomies by the senior author at an outpatient surgery center were recruited by a clinic nurse practitioner (GJ) during the routine pre-operative history and physical exam visit. Enrollment was opened from July of 2009 through June of 2012.
Pre-assignment Detail	28 subjects were recruited, 22 completed the study. One elected to leave the study prior to surgery, 2 attended only one post-operative visit; 2 did not undergo surgery (loss of health insurance [1] and thrombocytopenia [1]); and 1 subject elected to leave the study for laser treatments for ecchymosis on post-operative day 3

Arm/Group Title	Arnica Montana	Placebo
Arm/Group 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.
Period Title: Overall Study
STARTED	12	14
COMPLETED	9	13
NOT COMPLETED	3	1

Baseline Characteristics

Arm/Group Title	Arnica Montana	Placebo	Total
Arm/Group 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.	Total of all reporting groups
Overall Participants	12	14	26
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	12 100%	14 100%	26 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	34.75 (13.06)	32.71 (13.34)	33.65 (13.05)
Sex: Female, Male (Count of Participants)
Female	8 66.7%	7 50%	15 57.7%
Male	4 33.3%	7 50%	11 42.3%
Region of Enrollment (participants) [Number]
United States	12 100%	14 100%	26 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arnica Montana	Placebo
Arm/Group 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.
Measure Participants	9	13
Mean (Standard Error) [a ratio of pixels]	.617 (.091)	.736 (.118)

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arnica Montana	Placebo
Arm/Group 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.
Measure Participants	9	13
Mean (Standard Error) [a ratio of pixels]	.600 (.082)	.894 (.146)

3. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arnica Montana	Placebo
Arm/Group 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.
Measure Participants	9	13
Mean (Standard Error) [a ratio of pixels]	.432 (.125)	.543 (.094)

Adverse Events

Arm/Group Title	Arnica Montana		Placebo
Arm/Group 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.
All Cause Mortality
	Arnica Montana		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Arnica Montana		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/12 (8.3%)		0/14 (0%)
Blood and lymphatic system disorders
thrombocytopenia	1/12 (8.3%)		0/14 (0%)
Other (Not Including Serious) Adverse Events
	Arnica Montana		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/14 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.