Use of Pulsed Electromagnetic Fields (PEMF) After Breast Reconstruction Surgery
Condition: Other Reconstructive Surgery
Study type: Interventional
Phase: Phase 4

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 harvesting skin, fat, and muscle from the abdomen to create a new
      breast. TRAM flap complications include fat necrosis of the reconstructed breast, delayed
      wound healing, and abdominal bulge or hernia. Pain at the abdominal donor site is a major
      contributor to the need for four to five days of post-operative hospital stay. Pulsed
      electromagnetic field (PEMF) technologies have been useful as adjunctive therapy for the
      treatment of delayed union fractures, chronic wounds and post-operative pain. PEMF devices
      are economical and disposable, and can be incorporated unobtrusively in standard
      post-operative dressings. The investigators have recently reported, in a double-blind,
      placebo-controlled study on breast reduction, that post-op PEMF therapy produced a
      significant decrease in pain and pain medication use, along with a concomitant decrease in
      IL1-beta in the wound bed.

      The proposed study seeks to determine whether similar results will be obtained after a
      significantly more extensive surgical procedure, like the TRAM flap. Patients scheduled for
      pedicled TRAM flap breast reconstruction of a single breast immediately following mastectomy
      will be enrolled in this double-blind, placebo-controlled, randomized study. Subjects will be
      assigned to one of two groups: a treatment group with active PEMF devices and a placebo group
      with sham devices that deliver no PEMF. PEMF and sham devices will be taped over both the
      breast reconstruction and abdominal donor sites. Patients will keep the devices in place for
      their hospital stay and for a total of two weeks. The investigators hypothesize that subjects
      in the PEMF treatment group compared to placebo will have a faster reduction in pain, take
      less pain and nausea medications, have lower levels of IL1-beta in wound exudate, have a
      shorter hospital stay, and have less wound-healing complications.
    

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 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.
    

Intervention name(s): Sham PEMF Device; Ivivi Torino II PEMF Device
Intervention type(s): Device; Device
Intervention description(s): Inactive device placed in the same manner as the active device; does not deliver pulsed electromagnetic fields; 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.
Other intervention name(s): Ivivi Torino II
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Breast and abdomen morbidities after TRAM flap surgery; TRAM flap surgery; Post-mastectomy breast reconstructive surgery