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.
Breast and Abdomen Morbidities After TRAM Flap Surgery
Device: Sham PEMF Device
Device: Ivivi Torino II PEMF Device
|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|
- 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.
- 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.
|Study Start Date:||February 2010|
|Estimated Study Completion Date:||January 2014|
|Estimated Primary Completion Date:||January 2014 (Final data collection date for primary outcome measure)|
|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
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.
|Contact: Christine Rohde, MDemail@example.com|
|United States, New York|
|Columbia University Medical Center||Recruiting|
|New York, New York, United States, 10032|
|Contact: Christine Rohde, MD 212-342-3707 firstname.lastname@example.org|
|Principal Investigator: Christine Rohde, MD|
|Sub-Investigator: Jeffrey Ascherman, MD|
|Sub-Investigator: Krista Hardy, BS|
|Principal Investigator:||Christine Rohde, MD||Columbia University|