PREvention of Post-mastectomy LYMphoceles by PAdding

Mastectomy Clinical Trial

— PRELYMCA  

Official title:

PREvention of Post-mastectomy LYMphoceles by PAdding. A Randomized Prospective Multicenter Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02894021
• Other study ID #: PI2013_843_0001
• Status: Recruiting
• Phase: N/A
• First received: September 5, 2016
• Last updated: September 5, 2016
• Start date: May 2013
• Est. completion date: August 2017

Study information

• Verified date: September 2016
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: Mohamed AIT AMER MEZIANE, PhD
• Phone: +33 3 22 66 85 23
• Email: AitAmerMeziane.Mohamed[@]chu-amiens.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Lymphocele
• Mastectomy

Intervention

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

Locations

Country	Name	City	State
France	CHU Amiens	Amiens
France	CH Compiègne	Compiegne
France	CH Soissons	Soissons

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative lymphoceles	presence or absence of postoperative lymphoceles	Day 15	Yes