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

NCT01262599 | Completed Phase 4 Results DMC

• 1 other identifier: AAAE8848
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Other Reconstructive Surgery

Keywords

Breast and abdomen morbidities after TRAM flap surgery; TRAM flap surgery; Post-mastectomy breast reconstructive surgery

Outcome Measures

Primary Outcomes (1)

• 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.

  12 hours

Secondary Outcomes (2)

• Number of Narcotic Pain Medications

  24 hours

• Levels of Cytokines

  24 hours

Study Arms (2)

Sham PEMF Device

SHAM COMPARATOR

Patients will receive inactive device

Device: Sham PEMF Device

PEMF Device

ACTIVE COMPARATOR

Patients will receive Ivivi Torino II PEMF Device

Device: Ivivi Torino II PEMF Device

Interventions

Sham PEMF Device DEVICE

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

Sham PEMF Device

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.

Also known as: Ivivi Torino II

PEMF Device

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

Related Publications (2)

• Rohde C, Chiang A, Adipoju O, Casper D, Pilla AA. Effects of pulsed electromagnetic fields on interleukin-1 beta and postoperative pain: a double-blind, placebo-controlled, pilot study in breast reduction patients. Plast Reconstr Surg. 2010 Jun;125(6):1620-1629. doi: 10.1097/PRS.0b013e3181c9f6d3.

  PMID: 20527063 BACKGROUND

• Rohde CH, Taylor EM, Alonso A, Ascherman JA, Hardy KL, Pilla AA. Pulsed Electromagnetic Fields Reduce Postoperative Interleukin-1beta, Pain, and Inflammation: A Double-Blind, Placebo-Controlled Study in TRAM Flap Breast Reconstruction Patients. Plast Reconstr Surg. 2015 May;135(5):808e-817e. doi: 10.1097/PRS.0000000000001152.

  PMID: 25919263 DERIVED

Results Point of Contact

• Title: Dr. Christine Rohde
• Organization: Columbia University Medical Center

chr2111@columbia.edu

(212) 342-3707

Study Officials

• Christine Rohde, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Surgery

Study Record Dates

• First Submitted: December 1, 2010
• First Posted: December 17, 2010
• Study Start: February 1, 2010
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: September 25, 2018
• Results First Posted: August 10, 2015

Record last verified: 2018-08

Locations

US (1)