Clinical trial NCT03586232: Arnica Montana and Bromelain in Rhinoplasty
Official title: Effects of Arnica Montana and Bromelain in Rhinoplasty
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Wound Healing
Keywords: Rhinoplasty
Arnica Montana
Bromelain
Body healing post op
Rhinoplasty Outcome Evaluation
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
First posted: 2018-07-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Ecchymosis extent 7 days post rhinoplasty
timeFrame: 7 days
measure: Ecchymosis extent 14 days post rhinoplasty
timeFrame: 14 days
measure: Ecchymosis extent 28 days post rhinoplasty
timeFrame: 28 days
measure: Ecchymosis color density 7 days post rhinoplasty
timeFrame: 7 days
measure: Ecchymosis color density 14 days post rhinoplasty
timeFrame: 14 days
measure: Ecchymosis color density 28 days post rhinoplasty
timeFrame: 28 days
measure: Edema 7 days post rhinoplasty
timeFrame: 7 days
measure: Edema 14 days post rhinoplasty
timeFrame: 14 days
measure: Edema 28 days post rhinoplasty
timeFrame: 28 days
Secondary outcomes:
measure: Change in patient satisfaction
timeFrame: baseline, 28 days
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center
name: Jacqueline Wulu, MD
role: PRINCIPAL_INVESTIGATOR
References: