Status:
COMPLETED
Use of Pulsed Electromagnetic Fields (PEMF) After Breast Reconstruction Surgery
Lead Sponsor:
Columbia University
Conditions:
Other Reconstructive Surgery
Eligibility:
FEMALE
18-85 years
Phase:
PHASE4
Brief Summary
Pedicled transverse rectus abdominus myocutaneous (TRAM) flaps are the most common post-mastectomy breast reconstructive surgeries that utilize the patient's tissue. The pedicled TRAM flap involves ha...
Detailed Description
Operations will be performed by one of two plastic surgeons who perform this surgery in a similar manner. The entire unilateral rectus abdominis muscle will be harvested with fascial-sparing as part o...
Eligibility Criteria
Inclusion
- All patients who decide to have immediate unilateral TRAM flap breast reconstruction and are deemed candidates for this surgery. Patients who have undergone or will be undergoing sentinel lymph node or axillary lymph node dissection will be included.
Exclusion
- Patients who are not candidates for TRAM flap reconstruction will be excluded. Specific reasons for a patient not to be a candidate will be determined by the surgeon, but may include patients who have minimal abdominal tissue, patients with multiple medical co-morbidities, patients who have had prior abdominal surgeries that preclude a pedicled operation, or patients who are morbidly obese.
- Additionally, patients who opt for a free TRAM flap or DIEP flap will be excluded since their abdominal donor site morbidity is different than a pedicled TRAM flap.
- Patients undergoing bilateral reconstruction will also be excluded, because of the more extensive nature of the surgery and donor-site morbidity, which might confound results.
Key Trial Info
Start Date :
February 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT01262599
Start Date
February 1 2010
End Date
April 1 2014
Last Update
September 25 2018
Active Locations (1)
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1
Columbia University Medical Center
New York, New York, United States, 10032