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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01262599
First Posted: December 17, 2010
Last Update Posted: September 2, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Christine Hsu Rohde, MD, Columbia University
December 1, 2010
December 17, 2010
May 12, 2015
August 10, 2015
September 2, 2016
February 2010
April 2014   (Final data collection date for primary outcome measure)
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.
Reduction in Pain Level [ Time Frame: 4 days ]
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.
Complete list of historical versions of study NCT01262599 on ClinicalTrials.gov Archive Site
  • Amount of Narcotic Pain Medications [ Time Frame: 4 days ]
    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 ]
    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.
  • Amount of Narcotic Pain Medications [ Time Frame: 4 days ]
    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 ]

    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 ]
    The time it takes after surgery for the patient to be discharged.
  • Wound-healing complications [ Time Frame: 6 months ]
    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 ]
    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 ]
    In addition to pain medications, we will record the amount of nausea medications used until the patient is discharged.
Not Provided
Not Provided
 
Use of Pulsed Electromagnetic Fields (PEMF) After Breast Reconstruction Surgery
Effect of Pulsed Electromagnetic Fields on Postoperative Recovery After TRAM Flap Breast Reconstruction

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.

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.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Other Reconstructive Surgery
  • Device: Sham PEMF Device
    Inactive device placed in the same manner as the active device; does not deliver pulsed electromagnetic fields
  • 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. Supplied by Ivivi Health Sciences, LLC.
    Other Name: Ivivi Torino II
  • Sham Comparator: Sham PEMF Device
    Patients will receive inactive device
    Intervention: Device: Sham PEMF Device
  • Active Comparator: PEMF Device
    Patients will receive Ivivi Torino II PEMF Device
    Intervention: Device: Ivivi Torino II PEMF Device

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
April 2014
April 2014   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
18 Years to 85 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01262599
AAAE8848
Yes
Not Provided
Plan to Share IPD: Undecided
Christine Hsu Rohde, MD, Columbia University
Columbia University
Not Provided
Principal Investigator: Christine Rohde, MD Columbia University
Columbia University
July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP
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