Arnica Montana and Bromelain in Rhinoplasty

Effects of Arnica Montana and Bromelain in Rhinoplasty

The purpose of this study is to assess the perioperative use of Arnica Montana and the combined use of Arnica Montana and Bromelain in aiding the body's wound healing functions during the postoperative period after rhinoplasty. The secondary objective of the study is to determine if there is a reduction in postoperative edema when Arnica Montana and Bromelain are combined. Another secondary objective is to demonstrate increased patient satisfaction with the use of Arnica Montana and the combination Arnica Montana and Bromelain.

Study Overview

• Status: Withdrawn
• Conditions: Wound Healing
• Intervention / Treatment: Other: Placebo; Dietary supplement: Arnica Montana; Dietary supplement: Bromelain

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

-adults scheduled for outpatient primary rhinoplasty with osteotomies at Boston Medical Center

Exclusion Criteria:

• oral or contact allergies to Arnica Montana or to derivatives from the Ananas comosus or to any other member of the Asteraceae family of plants such as ragweed, chrysanthemums, marigolds, and daisies or Bromelain as determined by self disclosure.
• allergies to pineapple as Bromelain is from pineapple extract
• currently taking antiplatelet medication or anticoagulation medications
• chronic use of NSAIDs meaning those currently using NSAIDS daily for at least 3 months
• taking other homeopathic remedies during the perioperative period
• bleeding disorders as determined by self-disclosure or strong family history, patients in question who would like to participate in the study will have blood work obtained prior to operation
• chronic medical conditions such as significant pulmonary, cardiac, liver, or kidney disease are excluded including poorly controlled hypertension or patients on more than one antihypertensive agent and patients with diabetes
• malignancy, infection, immunodeficiency, metabolic syndrome, infectious, or inflammatory gastrointestinal disease
• severe liver or kidney disease
• significant psychiatric disorders
• females who are breast feeding or pregnant
• history of nasal surgery
• history of head and neck malignancy
• taking oral corticosteroid therapy
• undergoing additional surgery other than primary rhinoplasty

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control; Participants will take two placebo pills q8 hours for 7 days preoperatively and 7 days postoperatively, in addition to the standard postoperative tapered methylprednisolone.	Other: Placebo; A pharmacologically inert preparation
Experimental: Arnica Montana; Participants will take Arnica Montana, 30C oral, pill and a placebo pill q8 hours for 7 days preoperatively and 7 days postoperatively, in addition to the standard postoperative tapered methylprednisolone.	Other: Placebo; A pharmacologically inert preparation; Dietary supplement: Arnica Montana; Arnica Montana is from the Asteraceae plant family and is native to the mountain areas in Europe and western North America. It is reported to have anti-inflammatory, antiseptic, and vasodilatory properties and is often used in plastic surgery to help reduce pain, edema, and ecchymosis postoperatively.
Experimental: Arnica Montana and Bromelain; Participants will take Bromelain, 500mg oral pill + Arnica Montana, 30C oral, q8 hours for 7 days preoperatively and 7 days postoperatively, in addition to the standard postoperative tapered methylprednisolone.	Dietary supplement: Arnica Montana; Arnica Montana is from the Asteraceae plant family and is native to the mountain areas in Europe and western North America. It is reported to have anti-inflammatory, antiseptic, and vasodilatory properties and is often used in plastic surgery to help reduce pain, edema, and ecchymosis postoperatively.; Dietary supplement: Bromelain; Bromelain is a protease enzyme derived from the pineapple plant, Ananas comosus, which has been used to reduce swelling, inflammation, and pain and may help to reduce wound healing time.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ecchymosis extent 7 days post rhinoplasty	Blinded facial plastic surgeons will review 4 photographs of participants (1frontal, 2 oblique, and 1 nasal base view) and using the photo analysis scale by Totonchi and Guyuron assign each participant an average score based on the extent of the ecchymosis from 0-5 where 0= no ecchymosis, 1= up to medial one third of the lower and or upper eyelid, 2=medial half of the upper and or lower eyelid, 3=entire upper and lower eyelid, 4= entire lower and upper eyelid and or conjunctive, 5= extension of ecchymosis below the molar bone. Lower scores are more favorable.	7 days
Ecchymosis extent 14 days post rhinoplasty	Blinded facial plastic surgeons will review 4 photographs of participants (1frontal, 2 oblique, and 1 nasal base view) and using the photo analysis scale by Totonchi and Guyuron assign each participant an average score based on the extent of the ecchymosis from 0-5 where 0= no ecchymosis, 1= up to medial one third of the lower and or upper eyelid, 2=medial half of the upper and or lower eyelid, 3=entire upper and lower eyelid, 4= entire lower and upper eyelid and or conjunctive, 5= extension of ecchymosis below the molar bone. Lower scores are more favorable.	14 days
Ecchymosis extent 28 days post rhinoplasty	Blinded facial plastic surgeons will review 4 photographs of participants (1frontal, 2 oblique, and 1 nasal base view) and using the photo analysis scale by Totonchi and Guyuron assign each participant an average score based on the extent of the ecchymosis from 0-5 where 0= no ecchymosis, 1= up to medial one third of the lower and or upper eyelid, 2=medial half of the upper and or lower eyelid, 3=entire upper and lower eyelid, 4= entire lower and upper eyelid and or conjunctive, 5= extension of ecchymosis below the molar bone. Lower scores are more favorable.	28 days
Ecchymosis color density 7 days post rhinoplasty	Blinded facial plastic surgeons will review 4 photographs of participants (1frontal, 2 oblique, and 1 nasal base view) and using the photo analysis scale by Totonchi and Guyuron assign each participant an average score based on the the color density (intensity) of the ecchymosis from 0-5 where 0=no color change, 1= yellowish color change, 3: light purple, 4: dark purple, 5: very dark purple.Lower scores are more favorable.	7 days
Ecchymosis color density 14 days post rhinoplasty	Blinded facial plastic surgeons will review 4 photographs of participants (1frontal, 2 oblique, and 1 nasal base view) and using the photo analysis scale by Totonchi and Guyuron assign each participant an average score based on the the color density (intensity) of the ecchymosis from 0-5 where 0=no color change, 1= yellowish color change, 3: light purple, 4: dark purple, 5: very dark purple.Lower scores are more favorable.	14 days
Ecchymosis color density 28 days post rhinoplasty	Blinded facial plastic surgeons will review 4 photographs of participants (1frontal, 2 oblique, and 1 nasal base view) and using the photo analysis scale by Totonchi and Guyuron assign each participant an average score based on the the color density (intensity) of the ecchymosis from 0-5 where 0=no color change, 1= yellowish color change, 3: light purple, 4: dark purple, 5: very dark purple.Lower scores are more favorable.	28 days
Edema 7 days post rhinoplasty	Blinded facial plastic surgeons will review 4 photographs of participants (1 frontal, 2 oblique, and 1 nasal base view) and using the photo analysis scale by Totonchi and Guyuron assign each participant an average score based on the extent of the edema from 0-3 where 0=no edema, 1=mild edema, 2= moderate edema 3= severe edema. Lower scores are more favorable.	7 days
Edema 14 days post rhinoplasty	Blinded facial plastic surgeons will review 4 photographs of participants (1 frontal, 2 oblique, and 1 nasal base view) and using the photo analysis scale by Totonchi and Guyuron assign each participant an average score based on the extent of the edema from 0-3 where 0=no edema, 1=mild edema, 2= moderate edema 3= severe edema. Lower scores are more favorable.	14 days
Edema 28 days post rhinoplasty	Blinded facial plastic surgeons will review 4 photographs of participants (1 frontal, 2 oblique, and 1 nasal base view) and using the photo analysis scale by Totonchi and Guyuron assign each participant an average score based on the extent of the edema from 0-3 where 0=no edema, 1=mild edema, 2= moderate edema 3= severe edema. Lower scores are more favorable.	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in patient satisfaction	Participants will complete the validated Rhinoplasty Outcome Evaluation (ROE) at their initial consultation visit (preoperative responses) which will be compared to their postoperative survey to assess overall patient satisfaction in regards to their rhinoplasty one month postoperatively. The ROE questionnaire has 6 questions, each with 5 answer options, graded from 0 to 4 so scores can range from 0 to 24. In order to make understanding easier, the score obtained must be divided by 24 and multiplied by 100, which leads to a score varying between zero and 100, and the higher the score, the greater is the patient's satisfaction with the nose surgery.	baseline, 28 days

Collaborators and Investigators

• Sponsor: Boston Medical Center
• Investigators: Principal Investigator: Jacqueline Wulu, MD, Boston Medical Center

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2019
• Primary Completion (Anticipated): August 1, 2020
• Study Completion (Anticipated): August 1, 2020

Study Registration Dates

• First Submitted: July 3, 2018
• First Submitted That Met QC Criteria: July 3, 2018
• First Posted (Actual): July 13, 2018

Study Record Updates

• Last Update Posted (Actual): August 15, 2019
• Last Update Submitted That Met QC Criteria: August 13, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Rhinoplasty; Arnica Montana; Bromelain; Body healing post op; Rhinoplasty Outcome Evaluation
• Other Study ID Numbers: H-37291

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No