Trial Outcomes & Findings for The Utility of Peri-operative Arnica Montana for Reduction of Ecchymosis in Rhinoplasty Surgery (NCT NCT01164644)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

28 participants

Primary outcome timeframe

Post-operative day 3

Results posted on

2017-05-17

Participant Flow

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.

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

Participant milestones

Participant milestones
Measure	Arnica Montana The subject will take twelve pills by mouth three times a day over four days.	Placebo The subject will take twelve pills by mouth three times a day over four days.
Overall Study STARTED	12	14
Overall Study COMPLETED	9	13
Overall Study NOT COMPLETED	3	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arnica Montana n=12 Participants The subject will take twelve pills by mouth three times a day over four days.	Placebo n=14 Participants The subject will take twelve pills by mouth three times a day over four days.	Total n=26 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=99 Participants	14 Participants n=107 Participants	26 Participants n=206 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Continuous	34.75 years STANDARD_DEVIATION 13.06 • n=99 Participants	32.71 years STANDARD_DEVIATION 13.34 • n=107 Participants	33.65 years STANDARD_DEVIATION 13.05 • n=206 Participants
Sex: Female, Male Female	8 Participants n=99 Participants	7 Participants n=107 Participants	15 Participants n=206 Participants
Sex: Female, Male Male	4 Participants n=99 Participants	7 Participants n=107 Participants	11 Participants n=206 Participants
Region of Enrollment United States	12 participants n=99 Participants	14 participants n=107 Participants	26 participants n=206 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Arnica Montana n=9 Participants The subject will take twelve pills by mouth three times a day over four days.	Placebo n=13 Participants The subject will take twelve pills by mouth three times a day over four days.
Assess Extent of Bruising	.617 a ratio of pixels Standard Error .091	.736 a ratio of pixels Standard Error .118

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Arnica Montana n=9 Participants The subject will take twelve pills by mouth three times a day over four days.	Placebo n=13 Participants The subject will take twelve pills by mouth three times a day over four days.
Assess Extent of Bruising	.600 a ratio of pixels Standard Error .082	.894 a ratio of pixels Standard Error .146

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Arnica Montana n=9 Participants The subject will take twelve pills by mouth three times a day over four days.	Placebo n=13 Participants The subject will take twelve pills by mouth three times a day over four days.
Assess Extent of Bruising	.432 a ratio of pixels Standard Error .125	.543 a ratio of pixels Standard Error .094

Adverse Events

Arnica Montana

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arnica Montana n=12 participants at risk The subject will take twelve pills by mouth three times a day over four days.	Placebo n=14 participants at risk The subject will take twelve pills by mouth three times a day over four days.
Blood and lymphatic system disorders thrombocytopenia	8.3% 1/12	0.00% 0/14

Other adverse events

Adverse event data not reported

Additional Information

Dr. Scott R. Chaiet

University of Wisconsin School of Medicine and Public Health

Phone: (608) 263-1092

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place