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Arnica Montana and Bellis Perennis for Prevention of Seroma After Mastectomy (HOM)

Primary Purpose

Seroma

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Homeopathic Medication
Placebo
Sponsored by
Shaare Zedek Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Seroma focused on measuring Mastectomy, Breast Reconstruction, Homeopathic Treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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. -

Exclusion Criteria:

  • 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Study

    control

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    April 9, 2018
    Last Updated
    May 2, 2018
    Sponsor
    Shaare Zedek Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03512639
    Brief Title
    Arnica Montana and Bellis Perennis for Prevention of Seroma After Mastectomy
    Acronym
    HOM
    Official Title
    Arnica Montana and Bellis Perennis for Prevention of Seroma Following Mastectomy and Immediate Breast Reconstruction: Prospective, Randomized, Double-Blind, Placebo- Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2016 (Actual)
    Primary Completion Date
    August 1, 2017 (Actual)
    Study Completion Date
    April 1, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Shaare Zedek Medical Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Arnica montana and Bellis perennis for Prevention of Seroma Following Mastectomy.
    Detailed Description
    Background Seroma is a common surgical complication created by the inflammatory process that follows mastectomy and reconstruction. It is, thus, common practice to insert surgical drains, which often often remain in place for long periods and delay recovery. In light of the many advantages of holistic treatment, there has been a global trend of integrating them with conventional medicine. In this study, the investigators examined the effect of Arnica montana and Bellis perennis on seroma prevention after mastectomy and breast reconstruction. Study design The investigators conducted a prospective, double-blind, randomized, controlled study to asses the effect of homeopathic remedies on seroma in 55 patients (78 breasts), who had undergone mastectomy for cancer or risk reduction, followed by immediate implant and Acellular Dermal Matrix (ADM)-based breast reconstruction in the Department of Plastic & Reconstructive Surgery at Shaare Zedek Medical Center in Jerusalem, Israel, between January 2016 and August 2017 (Figure 1). The study protocol was approved by the Institutional Review Board and it was registered on the ClinicalTrials.gov register. Subjects All subjects were female, aged over 18 years, who underwent mastectomy, either for breast cancer or for risk reduction, followed by immediate breast reconstruction. In some patients, this was performed in a single procedure - direct to implant (DTI) (n=42); in others, it was in two stages tissue expander (TE) (n=36), depending on presurgical evaluation, risk factors and clinical assessment of perfusion of the mastectomy skin flaps. All subjects signed informed consent forms after receiving a detailed explanation of the study from one of its investigators. The investigators excluded patients with: (a) conditions which could affect wound-healing; (b) coagulation problems (autoimmune and hematological diseases, etc.); (c) taking medication which affects the immunological or hematological system (steroids, anticoagulants, chemotherapeutic agents, etc.); and (d) with unbalanced background diseases. Active smokers were instructed to stop smoking at least three weeks prior to surgery and a month postoperatively. Study medication and randomization and surgical techniques Experimental medications and placebos were prepared and delivered in accordance with the Homeopathic Pharmacopoeia of the United States (HPUS). Stem tinctures of Arnica montana, Bellis perennis and 40% alcohol as placebo were diluted 1:100 with 40% alcohol, and vigorously shaken. This process was repeated 30 times for a theoretical final concentration of 10-60 of the stem solutions. Spherical saccharose globules, approximately 1 mm in diameter, were wetted with the diluted tinctures and dried, resulting in three groups of the experimental medication: Arnica montana C30 (10-60), Bellis perennis C30 (10-60) and alcohol dilutions as placebo. 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. Age, body mass index, laterality of mastectomy, mastectomy type and number requiring sentinel lymph node biopsy and axillary dissection were similar between groups. The randomization sequence was created by an independent physician, uninvolved in the study, using computer-generated random numbers. 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. Three globules of each medication were regarded as a single dose, to be sucked rather than swallowed. Patients were hospitalized the night prior to surgery. On admission, a member of the study team again explained the study protocol, and gave the assigned medications to the patients. Patients were asked to take the medication according to the following protocol (Figure 2): One dose of A (3 pills) on the morning of surgery. One dose of A and one of B, 4 to 6 times a day for the first 24 hours after surgery (as soon as patients were stable, conscious and nausea- and vomit-free). One dose of A and one of B, 3 times a day until 4 days after surgery. Finally, one dose of B 3 times a day until removal of the surgical drain. All mastectomies were performed by experienced breast surgeons at our institution. Amputated breast-weight was documented. Sentinel lymph-node biopsy (SLNB) or axillary lymph-node dissection (ALND) was carried out according to the oncological status of each patient, either through a separate axillary incision or through the mastectomy incision. All reconstructions were subpectoral ADM-assisted, performed by plastic surgeons from our department. 42 breasts underwent the DTI procedure, and in 36 breasts a two-stage TE approach was taken, according to the patient's estimated breast volume, risk factors and intraoperative clinical evaluation of flap perfusion. ADM used was an 8*16 cm ADM. A 10-mm Jackson-Pratt drain was inserted through a subcutaneous tunnel in the lateral breast gutter at the level of the inframammary fold (IMF) (in the subcutaneous space). When axillary lymph node dissection (ALND) was performed through a separate incision, a second drain was placed in the axillary space. Drains were removed when drainage fell below 30 mL/24 hours. Assessment The following data for all patients were retrieved from their medical records: Baseline characteristics and demographic variables Medical history and risk factors - comorbidities, obesity, smoking, breast cancer (BRCA) mutation status Variables relating to the procedure - reason for surgery (breast cancer vs. risk reduction), breasts operated (unilateral or bilateral), size and type of implant (DTI vs. TE and implant volume) and lymph node status (no biopsy taken/sentinel lymph node biopsy (SLNB)/ALND) Postoperative course- time to drain removal, hemoglobin and cortisol levels on postoperative days (POD) 3 and 7, postoperative level of pain according to the visual analog (VAS) scale and Quality of Recovery. The VAS scale is a scale from 0 to 10, with 0 being "no pain at all" and 10 being "worst pain imaginable." The staff nurse caring for each patient administered the form and elicited the patient response for pain level according to the study protocol, and the quantity of narcotics taken. On POD 3 and 7, patients were given the Quality Of Recovery (QoR) 40 questionnaire, a validated questionnaire to measure postsurgical quality of recovery. Its scores range from 40 for very poor recovery to 200 for outstanding quality of recovery [49-51]. Postoperative complications: hematoma, skin-flap necrosis, infection, seroma, explantation and need for repeat surgery. Complications were divided into major and minor. Major complications included any of those mentioned above which required revision surgery in the operating room. Minor complications resolved spontaneously or were treated at the bedside. Data analysis All data were collected daily by a study coordinator. The investigators calculated the mean standard deviation (SD) and range for all quantitative variables, as well as their absolute frequencies and percentages. Statistical analyses were conducted using statistical software. The criterion for significance was: alpha (α) = .05 (one-sided).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Seroma
    Keywords
    Mastectomy, Breast Reconstruction, Homeopathic Treatment

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    RCT
    Masking
    ParticipantCare ProviderInvestigator
    Masking Description
    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.
    Allocation
    Randomized
    Enrollment
    55 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Study
    Arm Type
    Active Comparator
    Arm Description
    Patients in the study group were given homeopathic medication (Arnica montana C30 and Bellis perennis C30) .
    Arm Title
    control
    Arm Type
    Placebo Comparator
    Arm Description
    Patients in the control group were given placebo medication. The placebos and the active medication were indistinguishable in appearance, taste and smell
    Intervention Type
    Drug
    Intervention Name(s)
    Homeopathic Medication
    Other Intervention Name(s)
    Arnica montana and the Bellis perennis
    Intervention Description
    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
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    placebo was given to women in the control group following mastectomy and reconstruction to reduce post operative seroma
    Primary Outcome Measure Information:
    Title
    Reduction of post operative seroma following mastectomy and reconstruction.
    Description
    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.
    Time Frame
    18 months

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. - Exclusion Criteria: 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.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Arnica Montana and Bellis Perennis for Prevention of Seroma After Mastectomy

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