Arnica Montana and Bellis Perennis for Prevention of Seroma After Mastectomy

NCT03512639 | Completed

• 1 other identifier: 0136-16
• Study Type: interventional
• Target: 55
• Locations: 0 countries
• Sites: N/A

Brief Summary

Arnica montana and Bellis perennis for Prevention of Seroma Following Mastectomy.

Conditions

Seroma

Keywords

Mastectomy, Breast Reconstruction, Homeopathic Treatment

Outcome Measures

Primary Outcomes (1)

• Reduction of post operative seroma following mastectomy and reconstruction.

  Evaluate the effect of Arnica montana and Bellis perennis on seroma formation, measured in number of days to surgical drain removal, in patients undergoing mastectomy and reconstruction.

  18 months

Study Arms (2)

Study

ACTIVE COMPARATOR

Patients in the study group were given homeopathic medication (Arnica montana C30 and Bellis perennis C30) .

Drug: Homeopathic Medication

control

PLACEBO COMPARATOR

Patients in the control group were given placebo medication. The placebos and the active medication were indistinguishable in appearance, taste and smell

Drug: Placebo

Interventions

Homeopathic Medication DRUG

Homeopathic medication (Arnica montana and the Bellis perennis) were given to women in the study group following mastectomy and reconstruction to reduce post operative seroma

Also known as: Arnica montana and the Bellis perennis

Study

Placebo DRUG

placebo was given to women in the control group following mastectomy and reconstruction to reduce post operative seroma

control

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients, aged over 18 years.
• Patients underwent mastectomy, either for breast cancer or for risk reduction, followed by immediate breast reconstruction.
• All subjects signed informed consent forms. -

You may not qualify if:

• Conditions which could affect wound-healing
• Coagulation problems (autoimmune and hematological diseases, etc.)
• Medication which affects the immunological or hematological system (steroids, anticoagulants, chemotherapeutic agents, etc.)
• Unbalanced background diseases.
• Active smokers were instructed to stop smoking at least three weeks prior to surgery and a month postoperatively.

Sponsors & Collaborators

• Shaare Zedek Medical Center: lead

MeSH Terms

Conditions

Seroma

Interventions

Arnicae flos extract

Condition Hierarchy (Ancestors)

Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The medications were packed in bottles, each containing 5 grams of the preparation, and consecutively numbered. The prefix 'A' indicated Arnica montana, and 'B' Bellis perennis . Participants were randomly allocated into groups given either homeopathic medication (Arnica montana C30 and Bellis perennis C30) or placebo (alcohol 40% and alcohol 40%) in a 1:1 ratio. . The randomization code was held in confidence and the code was not broken until the data analysis. The same randomization list was used to blind the Arnica montana and the Bellis perennis, creating similar pairs. The placebos and the active medication were indistinguishable in appearance, taste and smell.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: RCT

Study Record Dates

• First Submitted: April 9, 2018
• First Posted: May 1, 2018
• Study Start: January 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: April 1, 2018
• Last Updated: May 7, 2018

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share