Use of Pulsed Electromagnetic Fields (PEMF) After Breast Reconstruction Surgery
Condition: Other Reconstructive Surgery
Intervention: Sham PEMF Device; Ivivi Torino II PEMF Device
Intervention description: 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.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 32.0
Sex: Female
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Breast and abdomen morbidities after TRAM flap surgery; TRAM flap surgery; Post-mastectomy breast reconstructive surgery

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.
    

Eligibility criteria:

        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.