Use of Pulsed Electromagnetic Fields (PEMF) After Breast Reconstruction Surgery
কীওয়ার্ডস
বিমূর্ত
বর্ণনা
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 of the pedicled TRAM flap. The flap will be shaped and sutured to the chest site, and the abdominal fascial defect will be closed primarily, followed by a polypropylene mesh overlay. Two 10 mm Jackson-Pratt (JP) drains will be placed in the flap wound, and two JPs will be placed in the abdominal wound. Immediately after transfer of the extubated patient to the recovery room bed, study devices will be placed on the reconstructed breast and abdominal donor sites, and activated. In the treatment arm, the PEMF signal is automatically delivered every two hours for fifteen minutes while the patient is in the hospital.
তারিখ
| সর্বশেষ যাচাই করা হয়েছে: | 07/31/2018 |
| প্রথম জমা দেওয়া: | 11/30/2010 |
| আনুমানিক তালিকাভুক্তি জমা দেওয়া হয়েছে: | 12/15/2010 |
| প্রথম পোস্ট: | 12/16/2010 |
| সর্বশেষ আপডেট জমা দেওয়া হয়েছে: | 08/26/2018 |
| সর্বশেষ আপডেট পোস্ট: | 09/24/2018 |
| প্রথম জমা দেওয়া ফলাফলের তারিখ: | 05/11/2015 |
| প্রথম জমা দেওয়া কিউসির ফলাফলের তারিখ: | 08/03/2015 |
| প্রথম পোস্ট ফলাফলের তারিখ: | 08/09/2015 |
| আসল অধ্যয়ন শুরুর তারিখ: | 01/31/2010 |
| আনুমানিক প্রাথমিক সমাপ্তির তারিখ: | 03/31/2014 |
| আনুমানিক অধ্যয়ন সমাপ্তির তারিখ: | 03/31/2014 |
অবস্থা বা রোগ
হস্তক্ষেপ / চিকিত্সা
Device: Sham PEMF Device
Device: PEMF Device
পর্যায়
বাহু গ্রুপ
| বাহু | হস্তক্ষেপ / চিকিত্সা |
|---|---|
| Sham Comparator: Sham PEMF Device Patients will receive inactive device | Device: Sham PEMF Device Inactive device placed in the same manner as the active device; does not deliver pulsed electromagnetic fields |
| Active Comparator: PEMF Device Patients will receive Ivivi Torino II PEMF Device | Device: PEMF Device The PEMF device to be employed in this study is FDA cleared for "adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue" (510(k) number: K903675). The PEMF device will be taped over the affected breast and abdomen. The PEMF signal will consist of a 2 msec burst of 27.12 MHz sinusoidal waves repeating at 2 bursts/sec. The device will automatically provide a 15 minute treatment every 2 hours. Supplied by Ivivi Health Sciences, LLC. |
যোগ্যতার মানদণ্ড
| বয়স অধ্যয়নের জন্য যোগ্য | 18 Years প্রতি 18 Years |
| লিঙ্গ অধ্যয়নের জন্য যোগ্য | Female |
| স্বাস্থ্যকর স্বেচ্ছাসেবীদের গ্রহণ করে | হ্যাঁ |
| নির্ণায়ক | Inclusion Criteria: - 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 Criteria: - 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. |
ফলাফল
প্রাথমিক ফলাফল ব্যবস্থা
1. Pain Score Measured by Visual Analog Scale [12 hours]
মাধ্যমিক ফলাফলের ব্যবস্থা
1. Number of Narcotic Pain Medications [24 hours]
2. Levels of Cytokines [24 hours]
