Low Level Laser Therapy to Reduce Pain After Breast Augmentation Surgery

NCT ID: NCT00926887

Last Updated: 2014-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-09-30
• Study Completion Date: 2007-07-31

Brief Summary

The goal of the clinical study was to see if applying low level laser light therapy to the breasts during breast implant surgery could lessen pain experienced by 24 hours after the surgery.

Detailed Description

Substantial pain, discomfort and swelling following breast augmentation surgery is not uncommon. The ability of low level laser therapy to reduce swelling and inflammation that subsequently reduces pain has been well documented. This study aimed to evaluate the ability of low level laser therapy to reduce post-operative pain and swelling for individuals undergoing bilateral breast augmentation surgery, by 24 hours post-surgery.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Placebo Laser

Placebo Laser is an inactive light

Group Type: SHAM_COMPARATOR

Placebo Laser

Intervention Type: DEVICE

Inactive light

Erchonia EML Laser

Erchonia EML Laser uses two 7mW red 635nm wavelength light emitting CSRH Class IIIb laser diodes. The energy delivered is 1.5 J/cm2.

Group Type: ACTIVE_COMPARATOR

Erchonia(R) EML Laser

Intervention Type: DEVICE

Low level laser red light of 635 nm and delivering 1.5 joules/cm2.

Interventions

Erchonia(R) EML Laser

Low level laser red light of 635 nm and delivering 1.5 joules/cm2.

Intervention Type: DEVICE

Placebo Laser

Inactive light

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Suitability for breast augmentation surgery based on the need for correction of a congenital deformity or condition such as: Amastia, Hypomastia, Hypoplasia, Pectus Carinatum, Pectus Excavatum, OR a cosmetic breast enhancement indication, including: Augmentation to increase breast size, correction of ptotic (drooping) or pendulous (sagging) breasts, recontouring to obtain enhanced breast shape.
• Bilateral breast augmentation indication only.
• 18 to 55 years, inclusive.
• Female, only.
• Willingness, and ability, to refrain from consuming over-the-counter and/or prescription medications for the indication of the relief of pain and/or swelling, including any non-steroidal anit-inflammatory drugs (NSAIDs), from 48 hours immediately prior to the laser-assisted breast implant procedure through to one week post-procedure.

Exclusion Criteria

• Breast augmentation procedures indicated for the purpose of breast reconstruction following mastectomy or an injury due to severe trauma.
• Presence of a specific connective tissue disorder.
• Inadequate tissue available to cover the implants.
• Consumption of any one or more of narcotics, opiates, and/or steroids.
• Inability to consume the following medications post-operatively due to allergy, intolerance, or any other reason:

(i) Pain medication for the relief of post-operative pain of Lortab 10/500 or another drug within the combination narcotic analgesic drug category within which Lortab falls.

(ii) Antibiotic medication for reducing the risk of post-operative infection of Keflex 500 mg or Cipro 500 mg or another drug within the broad-spectrum antibiotic drug category within which Keflex and Cipro fall.

• Developmental disability or cognitive impairment that impacts a subject's ability to read and/or to understand the content of the informed consent form, and/or impacts a subject's ability to read and /or to understand and/or to complete the required case report form information for the clinical study.
• Significant psychological disorder(s) for which treatment has become necessary, including anxiety and depression; psychiatric hospitalization.
• Pregnancy or lactation.
• Prior surgery to the breast area, or to the area of the intended incision.
• Infection or wound in the intended areas of treatment.
• Involvement in litigation and/or receiving disability benefits related to the subject's breast(s).
• Participation in research over the preceding 90 days.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Erchonia Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert F Jackson, MD, FACS

Role: PRINCIPAL_INVESTIGATOR

Gregory Roche, DO

Role: PRINCIPAL_INVESTIGATOR

Thomas L Jackson, MD

Role: PRINCIPAL_INVESTIGATOR

Related Links

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=25548

FDA 510(k)#K072206 clearance listing resulting from the outcome of this study

Other Identifiers

EBA-001

Identifier Type: -

Identifier Source: org_study_id