Status:
UNKNOWN
Suction Drain Versus the Use of Adaptive Skin Sutures After Mastectomy ± Axillary Lymphadenectomy; a Prospective Randomised Study
Lead Sponsor:
National Institute of Oncology, Hungary
Conditions:
in Situ Breast Cancer
Invasive Breast Cancer
Eligibility:
FEMALE
Up to 75 years
Phase:
PHASE3
Brief Summary
The objective of this prospective randomized study is to perform qualitative and quantitative comparisons between the insertion of traditional suction drains (Arm: Suction drain) versus the applicatio...
Eligibility Criteria
Inclusion
- female patients with primary unilateral, stage 0, I or II, T3N1M0 breast cancer necessitating simple or modified radical mastectomy
Exclusion
- age above 75 years and bad general state
- pregnancy
- autoimmune disease
- non-radical excision
- mastitis carcinomatosis
- lymphangitis carcinomatosis
- wound infection necessitating treatment
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT01509781
Start Date
September 1 2011
Last Update
October 6 2015
Active Locations (1)
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1
National Institute of Oncology
Budapest, Budapest, Hungary, 1122