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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:

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.


Sponsor: University of Wisconsin, Madison

Current Primary Outcome:

  • 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.
  • 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.
  • 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

    Original Primary Outcome: Assess Extent of Bruising [ Time Frame: Post-operative day 2 ]

    Primary outcome measure will be to measure the extent of bruising in square centimeters on post-operative day number two.


    Current Secondary Outcome:

    Original Secondary Outcome:

    Information By: University of Wisconsin, Madison

    Dates:
    Date Received: July 15, 2010
    Date Started: June 2010
    Date Completion:
    Last Updated: April 11, 2017
    Last Verified: April 2017