PREvention of Post-mastectomy LYMphoceles by PAdding

NCT ID: NCT02894021

Last Updated: 2016-09-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2017-08-31

Brief Summary

Lymphoceles, or seromas, are the most frequent complication following mastectomy and are associated or not with axillary dissection occurring in 10 to 90% of cases. It is defined as the presence of a palpable post operative serous accumulation that is bothersome for the patient and requires a puncture and drainage or even several repeated punctures. The presence of seromas is therefore associated with discomfort and pain. Seromas could also be responsible for increased morbidity due to complications such as infection, suture separating, lymphedema, prolonged of hospital stay, or a delay in initiation of adjunct treatment (e.g. chemotherapy, radiotherapy). Some risk factors have been identified, such as obesity, increased post operative drainage of J1 to J3, and arterial hypertension.

Different measures have demonstrated the benefits of limiting axillary lymphoceles after dissection : placement of a drain, padding and delay in shoulder mobility.

Studies have shown that axillary padding decreases lymphocele development and shortens the length of hospital stay. Some studies based on padding of the mastectomy site also have shown a decrease in post operative seromas; however no study has been done on the usefulness of padding in the mastectomy site alone because they include both padding and a drain or padding of the axillary area.

The padding technique the investigators employ is performed at the donor site in breast reconstruction by latissimus dorsi muscle flap, demonstrating a reduction in the rate of seromas.

In this study, the classic technique will be compared to padding in the mastectomy site with short drainage (48h).

Conditions

Mastectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

classic closure

mastectomy with classic closure in 2 steps, drainage by negative pressure aspiration

Group Type: ACTIVE_COMPARATOR

classic closure

Intervention Type: PROCEDURE

mastectomy with classic closure in 2 steps, drainage by negative pressure aspiration

padding

areas of padding and stiching between subcutaneous tissue and pectoral muscle followed by closure in 2 steps, drainage by negative pressure aspiration for 48 h.

Group Type: EXPERIMENTAL

padding

Intervention Type: PROCEDURE

areas of padding and running sutures between subcutaneous tissue and pectoral muscle followed by closure in 2 steps, drainage by negative pressure aspiration for 48 h

Interventions

classic closure

mastectomy with classic closure in 2 steps, drainage by negative pressure aspiration

Intervention Type: PROCEDURE

padding

areas of padding and running sutures between subcutaneous tissue and pectoral muscle followed by closure in 2 steps, drainage by negative pressure aspiration for 48 h

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 years
• Female gender
• Patients with infiltrating or in situ breast cancer
• Indication of surgical treatment by mastectomy
• Patient providing written informed consent
• Patient with health insurance coverage
• Ability to provide voluntary written informed consent

Exclusion Criteria

• Informed consent cannot be obtain
• Pregnant or lactating women
• Patients undergoing immediate breast reconstruction
• Patients with cancer untreatable by mastectomy, non curative mastectomy: partial mastectomies, preventive mastectomies (BRCA genetic mutations)
• Patients under legal protection or unable to come to a center
• Patients unable to express voluntary consent
• Patients receiving post operative anticoagulants or platelet antiaggregants
• Patients requiring postoperative anticoagulants
• Bilateral mastectomy

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU Amiens

Amiens, , France

Site Status: RECRUITING

CH Compiègne

Compiègne, , France

Site Status: RECRUITING

CH Soissons

Soissons, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Mohamed AIT AMER MEZIANE, PhD

Role: CONTACT

AitAmerMeziane.Mohamed@chu-amiens.fr

+33 3 22 66 85 23

Facility Contacts

Mohamed AIT AMER MEZIANE, PhD

Role: primary

AitAmerMeziane.Mohamed@chu-amiens.fr

+33 3 22 66 85 23

Johanna MYCHALUK, MD

Role: primary

Pascal ABBOUD, MD

Role: primary

Other Identifiers

PI2013_843_0001

Identifier Type: -

Identifier Source: org_study_id