Arnica Montana and Bromelain in Rhinoplasty

NCT03586232 | Withdrawn

• 1 other identifier: H-37291
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Wound Healing

Keywords

Rhinoplasty; Arnica Montana; Bromelain; Body healing post op; Rhinoplasty Outcome Evaluation

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (1)

• Change in patient satisfaction

  baseline, 28 days

Study Arms (3)

Control

PLACEBO COMPARATOR

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

Arnica Montana

EXPERIMENTAL

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; Other: Placebo

Arnica Montana and Bromelain

EXPERIMENTAL

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; Dietary Supplement: Bromelain

Interventions

Arnica Montana DIETARY_SUPPLEMENT

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.

Arnica Montana; Arnica Montana and Bromelain

Bromelain DIETARY_SUPPLEMENT

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.

Arnica Montana and Bromelain

Placebo OTHER

A pharmacologically inert preparation

Arnica Montana; Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Medical Center: lead

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Interventions

Arnicae flos extract; Bromelains

Intervention Hierarchy (Ancestors)

Cysteine Endopeptidases; Cysteine Proteases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Endopeptidases

Study Officials

• Jacqueline Wulu, MD

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2018
• First Posted: July 13, 2018
• Study Start: August 1, 2019
• Primary Completion: August 1, 2020
• Study Completion: August 1, 2020
• Last Updated: August 15, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)