Other Reconstructive Surgery
Conditions
Keywords
Breast and abdomen morbidities after TRAM flap surgery, TRAM flap surgery, Post-mastectomy breast reconstructive surgery
Brief 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.
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.
Interventions
DEVICESham PEMF Device
Inactive device placed in the same manner as the active device; does not deliver pulsed electromagnetic fields
DEVICEIvivi 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.
Sponsors
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Score Measured by Visual Analog Scale | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Narcotic Pain Medications | 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 |
| Levels of Cytokines | 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. |
Countries
United States
Participant flow
Recruitment details
Recruited from medical offices of two participating plastic surgeons.
Participants by arm
| Arm | Count |
|---|---|
| Sham PEMF Device Sham PEMF Device: Inactive device placed in the same manner as the active device; does not deliver pulsed electromagnetic fields | 16 |
| PEMF 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. | 16 |
| Total | 32 |
Baseline characteristics
| Characteristic | Sham PEMF Device | PEMF Device | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants | 15 Participants | 30 Participants |
| Age, Continuous | 53.5 years STANDARD_DEVIATION 9.1 | 51.1 years STANDARD_DEVIATION 9.7 | 52.3 years STANDARD_DEVIATION 9.3 |
| Body Mass Index (BMI) | 25.1 kg/m2 STANDARD_DEVIATION 3.1 | 24.5 kg/m2 STANDARD_DEVIATION 3.4 | 24.8 kg/m2 STANDARD_DEVIATION 3.2 |
| Region of Enrollment United States | 16 participants | 16 participants | 32 participants |
| Sex: Female, Male Female | 16 Participants | 16 Participants | 32 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 16 | 0 / 16 |
| serious Total, serious adverse events | 0 / 16 | 0 / 16 |
Outcome results
Primary
Pain Score Measured by Visual Analog Scale
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.
Time frame: 12 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sham PEMF Device | Pain Score Measured by Visual Analog Scale | 3.48 units on a scale | Standard Deviation 0.61 |
| PEMF Device | Pain Score Measured by Visual Analog Scale | 1.67 units on a scale | Standard Deviation 0.43 |
Comparison: Before the start of this study, a sample size analysis, assuming a clinically meaningful 50± 40 percent (mean ± SD) decrease in pain scores from pulsed electromagnetic field treatment, suggested that a minimum of 11 patients per group were needed.p-value: <0.01ANOVA
Secondary
Levels of Cytokines
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.
Time frame: 24 hours
Population: data reported at 24 hours postop
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sham PEMF Device | Levels of Cytokines | 320 pg/ml | Standard Deviation 36 |
| PEMF Device | Levels of Cytokines | 168 pg/ml | Standard Deviation 17 |
Secondary
Number of Narcotic Pain Medications
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
Time frame: 24 hours
Population: data reported at 24 hours postop
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sham PEMF Device | Number of Narcotic Pain Medications | 34 pills | Standard Deviation 2.8 |
| PEMF Device | Number of Narcotic Pain Medications | 20 pills | Standard Deviation 1.8 |