PREvention of Post-mastectomy LYMphoceles by PAdding

NCT02894021 | Unknown

• 1 other identifier: PI2013_843_0001
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 3

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

Keywords

padding; lymphoceles; prevention

Outcome Measures

Primary Outcomes (1)

• postoperative lymphoceles

  presence or absence of postoperative lymphoceles

  Day 15

Study Arms (2)

classic closure

ACTIVE COMPARATOR

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

Procedure: classic closure

padding

EXPERIMENTAL

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.

Procedure: padding

Interventions

classic closure PROCEDURE

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

classic closure

padding 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

padding

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (3)

CHU Amiens

Amiens, 80054, France

RECRUITING

CH Compiègne

Compiègne, 60321, France

RECRUITING

CH Soissons

Soissons, 02209, France

RECRUITING

MeSH Terms

Conditions

Lymphocele

Condition Hierarchy (Ancestors)

Cysts; Neoplasms; Lymphatic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Mohamed AIT AMER MEZIANE, PhD

CONTACT

+33 3 22 66 85 23; AitAmerMeziane.Mohamed@chu-amiens.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2016
• First Posted: September 9, 2016
• Study Start: May 1, 2013
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: September 9, 2016

Record last verified: 2016-09

Locations

FR (3)