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Completed

NCT Number: NCT01262599

Use of Pulsed Electromagnetic Fields (PEMF) After Breast Reconstruction Surgery

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.

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Key information

Conditions

Other Reconstructive Surgery

Age range

18 year–85 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Columbia University Medical Center

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sham PEMF device

Device

Inactive device placed in the same manner as the active device; does not deliver pulsed electromagnetic fields

Ivivi Torino II PEMF Device

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.

Other names: Ivivi Torino II

Primary outcomes

  1. Pain Score Measured by Visual Analog Scale

    Time frame: 12 hours

    We will record postoperative pain, as reported by the patient and quantified by a standardized visual analog scale (VAS), with written descriptions at 12 hours post-op and assess that pain level in comparison with previous timepoint pain levels, such as 1 hour post-op. The VAS pain scale ranges from 0 (no pain) to 10 (worst possible pain). Higher scores indicate more pain and lower scores indicate less pain. The mean VAS score at 12 hours is reported for each group, active or placebo.

Secondary outcomes

  1. Number of Narcotic Pain Medications

    Time frame: 24 hours

    We will record the amount of pain medication used at twelve hour intervals for the duration of the hospital stay. Pain medications will be converted to oxycodone/acetaminophen equivalents for statistical analysis

  2. Levels of Cytokines

    Time frame: 24 hours

    Concentration of the cytokines IL1-beta in the wound bed. Exudates will be collected from standard Jackson-Pratt #10 drains until the patient is discharged. IL1-beta is an early central proinflammatory cytokine that induces cyclooxygenase, an enzyme responsible for prostaglandin synthesis. A decrease in IL1-beta correlates with a decrease in pain. Cytokines and growth factors may contribute to more rapid post-op pain reduction and healing.

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Registry information

Official study title

Effect of Pulsed Electromagnetic Fields on Postoperative Recovery After TRAM Flap Breast Reconstruction

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Dec 17, 2010
Registry last updated
Sep 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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