Use of Microporous Polysaccharide Hemispheres in Breast Cancer Patients Undergoing Mastectomy

NCT06824831 | Completed Phase 4 DMC FDA Drug

• 1 other identifier: Arista_HCUV
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

You should know that your participation in this study is voluntary and that you may decide NOT to participate. If you decide to participate, you may change your decision and withdraw your consent at any time, without altering your relationship with your physician or harming your health care. The presence of seroma (accumulation of fluid in the surgical area) is a very common complication after mastectomy and axillary emptying, it can occur in up to 50% of cases. Its presence entails the need to wear a drain for days and causes numerous visits to the surgery office and/or emergency room for control of the drain itself or for puncture of the seroma that develops after removal of the drain. The aim of the study is to assess whether the use of powdered hemostatics (microporous polysaccharide hemispheres whose commercial name is AristaTM) on the surgical bed reduces seroma formation after removal of the whole breast or all the fat in the axilla (mastectomy or axillary emptying). In the case of being able to demonstrate the benefits of its use, the discomfort of carrying an aspiration drain for a long time could be avoided, and the possibility of complications secondary to the use of the same could be reduced. The main characteristics of the present study are:

• The total number of patients included in the study will be 120.
• The study will include all patients diagnosed with breast cancer in whom it is necessary to perform a mastectomy, whether or not associated with axillary emptying. If you are included in the study you may be included in one of the two groups (control group and study group). In the study group AristaTM will be used in the surgical bed after surgery, while in the control group AristaTM will not be used. In both groups, aspirative drains and chest bandage will be used after surgery.
• Assignment to one group or the other will take place at the time of surgery and will be randomized.
• The duration of the study will be until the total number of patients required is completed.
• The number of visits and controls will depend on the time it is necessary to carry the drainage or on the persistence of the seroma. It will not be different from the usual one in case you decide not to participate in the study.
• No additional tests or complementary explorations will be necessary for participating in the study. The only thing necessary will be the strict control of the daily debit accumulated in the drainage canister while you are carrying it, this control is also necessary and does not differ in case you decide not to participate in the study. No additional risk is foreseen since no procedure outside the usual clinical practice is going to be performed. You may not gain any health benefit from participating in this study, but you may help to learn about the usefulness of the AristaTM by avoiding the occurrence of seroma or the discomfort of wearing a drain for a long time in future patients requiring an intervention such as yours. The data collected for the study will be identified by a code, so that it does not include information that can identify you, and only your study doctor/collaborators will be able to relate this data to you and your medical history. Therefore, your identity will not be disclosed to anyone except in the case of a medical emergency or legal requirement. Access to your personally identifiable information will be restricted to the study physician/collaborators, competent authorities, the Research Ethics Committee and personnel authorized by the sponsor (study monitors, auditors), when required to verify the study data and procedures, but always maintaining the confidentiality of the same in accordance with current legislation. If you decide to withdraw your consent to participate in this study, no new data will be added to the database, but the data already collected will be used. In addition, you can limit the processing of data that are incorrect, request a copy or have the data you have provided for the study transferred to a third party (portability). The encrypted data may be transmitted to third parties and other countries, but in no case will it contain information that can directly identify you, such as your first and last name, initials, address, social security number, etc. In the event that this transfer occurs, it will be for the same purposes of the study described or for use in scientific publications, but always maintaining the confidentiality of the same in accordance with current legislation. Your participation in this study does NOT involve the collection and use of biological samples.

Conditions

Mastectomy; Lymphadenectomy; Breast Neoplasm Malignant Female; Breast Surgery; Seroma Following Procedure

Keywords

breast cancer; breast surgery; lymphadenectomy; seroma

Outcome Measures

Primary Outcomes (1)

• Incidence of patients presenting seroma formation after mastectomy with or without axillary lymphadenectomy.

  -Number of patients presenting seroma after mastectomy with or without axillary lymphadenectomy in the case and control group.

  From enrollment to the end of treatment at 2 years

Secondary Outcomes (9)

• Time until the drain was removed after mastectomy with of without lymphadenectomy.

  From enrollment to the end of treatment at 2 years

• Amount of volume in the drains until it is removed after mastectomy with of without lymphadenectomy.

  From enrollment to the end of treatment at 2 years

• Time until seroma resolution after mastectomy with of without lymphadenectomy

  From enrollment to the end of treatment at 2 years

• Outpatient clinic visits after mastectomy with of without lymphadenectomy.

  From enrollment to the end of treatment at 2 years

• Aspiration punctures after mastectomy with of without lymphadenectomy.

  From enrollment to the end of treatment at 2 years

Study Arms (2)

Patients receive microporous polysaccharide hemospheres (treatment arm)

ACTIVE COMPARATOR

Drug: Patients receive microporous polysaccharide hemospheres.

Patients NOT receive microporous polysaccharide hemospheres (control arm)

OTHER

Drug: Patients DO NOT receive microporous polysaccharide hemospheres.

Interventions

Patients receive microporous polysaccharide hemospheres. DRUG

Patients were randomized to receive microporous polysaccharide hemospheres, after mastectomy was done.

Patients receive microporous polysaccharide hemospheres (treatment arm)

Patients DO NOT receive microporous polysaccharide hemospheres. DRUG

Patients were randomized to NOT receive microporous polysaccharide hemispheres after mastectomy was done.

Patients NOT receive microporous polysaccharide hemospheres (control arm)

Eligibility Criteria

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

You may qualify if:

• Patients (male and female) over 18 years of age.
• Patients diagnosed with breast cancer and scheduled for surgical treatment either simple mastectomy or mastectomy plus axillary mastectomy or mastectomy plus axillary emptying.
• Patients who sign the informed consent for mastectomy and/or mastectomy plus axillary emptying.
• axillary emptying.
• Patients who agree to participate in the study.

You may not qualify if:

• Patients diagnosed with locally advanced breast cancer requiring extensive resection requiring reconstruction with extensive skin or myocutaneous flaps.

Sponsors & Collaborators

• Fundación para la Investigación del Hospital Clínico de Valencia: lead

Study Sites (1)

Hospital Clínico Universitario

Valencia, Valencia, 46010, Spain

Location

Related Publications (1)

• Egeli T, Sevinc AI, Bora S, Yakut MC, Cevizci T, Canda T, Sisman AR. Microporous polysaccharide hemospheres and seroma formation after mastectomy and axillary dissection in rats. Balkan Med J. 2012 Jun;29(2):179-83. doi: 10.5152/balkanmedj.2012.005. Epub 2012 Jun 1.

  PMID: 25206991 BACKGROUND

Related Links

• Food and Drug Administration. Summary of safety and effectiveness
• BD. Arista™ AH Absorbable Hemostat

MeSH Terms

Conditions

Breast Neoplasms; Seroma

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: January 25, 2025
• First Posted: February 13, 2025
• Study Start: June 1, 2020
• Primary Completion: July 1, 2022
• Study Completion: September 2, 2024
• Last Updated: February 13, 2025

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)