Arnica Montana and Bromelain in Rhinoplasty

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Arnica Montana and Bromelain in Rhinoplasty

Conditions
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Wound Healing

Intervention / Treatment
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* Dietary Supplement: Arnica Montana
* Dietary Supplement: Bromelain
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>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<br>* A pharmacologically inert preparation<br>|
| Experimental: Arnica Montana<br>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. | Dietary Supplement: Arnica Montana<br>* 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.<br>Other: Placebo<br>* A pharmacologically inert preparation<br>|
| Experimental: Arnica Montana and Bromelain<br>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<br>* 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.<br>Dietary Supplement: Bromelain<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rhinoplasty, Arnica Montana, Bromelain, Body healing post op, Rhinoplasty Outcome Evaluation