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

This study has been completed.
Sponsor:
Collaborator:
Ivivi Health Sciences, LLC
Information provided by (Responsible Party):
Christine Hsu Rohde, MD, Columbia University
ClinicalTrials.gov Identifier:
NCT01262599
First received: December 1, 2010
Last updated: April 4, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Breast and Abdomen Morbidities After TRAM Flap Surgery
Device: Sham PEMF Device
Device: Ivivi Torino II PEMF Device
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Pulsed Electromagnetic Fields on Postoperative Recovery After TRAM Flap Breast Reconstruction

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Reduction in Pain Level [ Time Frame: 4 days ] [ Designated as safety issue: No ]
    We will record postoperative pain, as reported by the patient and quantified by a standardized visual analog scale (VAS) with written descriptions every 6 hours post-op, then 3 times a day for the first 2 days, and twice a day afterward until discharged.


Secondary Outcome Measures:
  • Amount of Narcotic Pain Medications [ Time Frame: 4 days ] [ Designated as safety issue: No ]
    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

  • Levels of Cytokines [ Time Frame: 4 days ] [ Designated as safety issue: No ]

    Concentration of the cytokines IL1-beta, TGF-alpha, and TNF-alpha and metabolites 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.


  • Length of Hospital Stay [ Time Frame: 1 day to 1 week ] [ Designated as safety issue: No ]
    The time it takes after surgery for the patient to be discharged.

  • Wound-healing complications [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    We will assess the rate of wound healing complications or fat necrosis at the breast or abdominal sites. PEMF is known to increase angiogenesis both in vitro and in vivo. It has also been shown to increase skin microvascular blood flow and to be useful for healing diabetic ulcers.

  • Levels of Angiogenic Factors [ Time Frame: 4 days ] [ Designated as safety issue: No ]
    Concentration of angiogenic factors VEGF, FGF2,and prostaglandin E2 (PGE2) and metabolites in wound exudate collected from Jackson-Pratt (JP) #10 drains, which are normally placed in the breast and abdomen. Angiogenic factors play a role in wound healing.

  • Amount of Narcotic Nausea Medications [ Time Frame: 4 days ] [ Designated as safety issue: No ]
    In addition to pain medications, we will record the amount of nausea medications used until the patient is discharged.


Enrollment: 32
Study Start Date: February 2010
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: Sham PEMF 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 Device: Ivivi Torino II 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.
Other Name: Ivivi Torino II

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01262599

Locations
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Ivivi Health Sciences, LLC
Investigators
Principal Investigator: Christine Rohde, MD Columbia University
  More Information

Publications:
Responsible Party: Christine Hsu Rohde, MD, Assistant Professor of Clinical Surgery, Columbia University
ClinicalTrials.gov Identifier: NCT01262599     History of Changes
Other Study ID Numbers: AAAE8848
Study First Received: December 1, 2010
Last Updated: April 4, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on July 24, 2014