Status:
COMPLETED
Dead Space Closure With Quilting Suture Versus Conventional Closure With Drainage
Lead Sponsor:
University Hospital, Tours
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-85 years
Phase:
NA
Brief Summary
The objective of this study is to compare quilting suture of the "dead space" without drainage of the pectoral area to conventional closure with drainage to prevent post-operative seroma requiring int...
Detailed Description
Eligible patients are patients with operable breast cancer (invasive carcinoma and/or carcinoma in situ) for whom mastectomy is recommended or preferred by the patient either alone or in association w...
Eligibility Criteria
Inclusion
- Women ≥ 18 years and ≤ 85 years
- Women with operable breast cancer (invasive carcinoma and/or carcinoma in situ) for whom mastectomy is recommended or preferred by the patient either alone or in association with sentinel lymph node biopsy or standard level I/II axillary node dissection
- Women that give her informed written consent
- French social security affiliation
Exclusion
- Any physical or psychiatric condition that could impair with patient's ability to cooperate with postoperative data collection.
- Women with indication of bilateral mastectomy or immediate reconstruction.
- Degenerative neuromuscular disease with thoracic muscular damage
- Planned ambulatory surgery
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2018
Estimated Enrollment :
320 Patients enrolled
Trial Details
Trial ID
NCT02263651
Start Date
October 1 2014
End Date
October 1 2018
Last Update
October 22 2018
Active Locations (6)
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1
Conception Hospital
Marseille, France, 13005
2
Institut POALI-CALMETTES
Marseille, France, 13009
3
Institut de Cancérologie de l'Ouest
Nantes, France
4
CHU de Poitiers
Poitiers, France