Status:
COMPLETED
Tissue Expander/Implant Reconstruction: A Single-Blinded, Randomized, Controlled Trial
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
University of Michigan
University of North Carolina, Chapel Hill
Conditions:
Breast Cancer
Eligibility:
FEMALE
21-75 years
Phase:
PHASE3
Brief Summary
Following mastectomy (removal of your breast), reconstruction of your breast(s) can be performed using tissue expanders and implants. At the same operation as your mastectomy, a tissue expander is put...
Eligibility Criteria
Inclusion
- Patients who undergo immediate, postmastectomy, tissue expander/implant reconstruction
- Patients ≥ 21 and ≤ 75 years of age
Exclusion
- Patient refusal
- Patients who will undergo any of the following:
- Single-stage implant reconstruction
- Combined autogenous tissue expander/implant reconstruction
- Patients with a history of prior irradiation
- Patients with a history of prior surgery with breast implants
- Patients with a history of prior axillary lymph node dissection
- Patients who are pregnant
- The following eligibility will be confirmed at the time of surgery.
- Patients who are deemed intraoperatively by the attending surgeon to have significant mastectomy flap ischemia.
- Patients who have an axillary lymph node dissection at the time of mastectomy (Patients undergoing sentinel lymph biopsy are eligible)
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2018
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00639106
Start Date
March 1 2008
End Date
October 1 2018
Last Update
October 3 2018
Active Locations (3)
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1
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109
2
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
3
University of North Carolina School of Medicine
Chapel Hill, North Carolina, United States, 27514