Ecchymosis
Conditions
Keywords
ecchymosis, bruising, rhinoplasty, nose job, arnica, arnica montana
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.
Interventions
DRUGArnica montana
Subjects will take twelve pills by mouth three times a day over four days.
DRUGPlacebo
Subjects will take twelve pills by mouth three times a day over four days.
Sponsors
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
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. \-
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
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 details
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
Participants by arm
| Arm | Count |
|---|---|
| Arnica Montana The subject will take twelve pills by mouth three times a day over four days. | 12 |
| Placebo The subject will take twelve pills by mouth three times a day over four days. | 14 |
| Total | 26 |
Baseline characteristics
| Characteristic | Placebo | Arnica Montana | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants | 12 Participants | 26 Participants |
| Age, Continuous | 32.71 years STANDARD_DEVIATION 13.34 | 34.75 years STANDARD_DEVIATION 13.06 | 33.65 years STANDARD_DEVIATION 13.05 |
| Region of Enrollment United States | 14 participants | 12 participants | 26 participants |
| Sex: Female, Male Female | 7 Participants | 8 Participants | 15 Participants |
| Sex: Female, Male Male | 7 Participants | 4 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 12 | 0 / 14 |
| serious Total, serious adverse events | 1 / 12 | 0 / 14 |
Outcome results
Primary
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.
Time frame: Post-operative day 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arnica Montana | Assess Extent of Bruising | .617 a ratio of pixels | Standard Error 0.091 |
| Placebo | Assess Extent of Bruising | .736 a ratio of pixels | Standard Error 0.118 |
Primary
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.
Time frame: Post-operative day 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arnica Montana | Assess Extent of Bruising | .600 a ratio of pixels | Standard Error 0.082 |
| Placebo | Assess Extent of Bruising | .894 a ratio of pixels | Standard Error 0.146 |
Primary
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.
Time frame: Post-operative day 10
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arnica Montana | Assess Extent of Bruising | .432 a ratio of pixels | Standard Error 0.125 |
| Placebo | Assess Extent of Bruising | .543 a ratio of pixels | Standard Error 0.094 |