Use of Microporous Polysaccharide Hemispheres in Breast Cancer Patients Undergoing Mastectomy

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

Interventions

DRUG

Patients receive microporous polysaccharide hemospheres.

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

DRUG

Patients DO NOT receive microporous polysaccharide hemospheres.

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

Sponsors & Collaborators

• Fundación para la Investigación del Hospital Clínico de Valencia

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-06-01

Primary Completion

2022-07-01

Completion

2024-09-02

FDA Drug

Yes

Countries

• Spain

Study Locations