Low Level Laser Therapy to Reduce Pain After Breast Augmentation Surgery

NCT00926887 | Completed Results

• 1 other identifier: EBA-001
• Study Type: interventional
• Target: 104
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pain

Outcome Measures

Primary Outcomes (2)

• Number of Participants Who Scored Less Than 30 on the 0-100 Visual Analog Scale (VAS)for Pain 24 Hours Post-operative.

  Self-reported Degree of Pain rating using the standardized 0-100 Visual Analog Scale (VAS) scale provided at 24 hours post-implant procedure, at which time the subject will not have taken any pain medication for at least four hours. The VAS ratings range from 0 to 100, where '0' represents 'no pain at all' and '100' represents 'worst pain imaginable.' A VAS of 30 is indicated as a cutoff threshold for 'success.' Participants who recorded a VAS rating of less than 30 were considered study 'successes' and are reported below.

  24 hours post-operative

• Self-reported Pain Rating on the 0-100 VAS 24 Hours Post-operative.

  Self-reported Degree of Pain rating using the standardized 0-100 VAS scale provided at 24 hours post-implant procedure, at which time the subject will not have taken any pain medication for at least four hours. VAS values range from '0' representing 'no pain at all' to '100' representing 'worst pain imaginable.'

  24 hours

Secondary Outcomes (6)

• Swelling Evaluation Through Length by Width Breast Diameter Measurements

  immediately, 24 hours & 7 days post surgery

• Self-reported Degree of Pain Rating in the Breasts Area.

  24 hours, 7 days, 14 days & 28 days post surgery

• Use of Pain Management Medication Post-surgically.

  Through the 1st 7 post-operative days.

• Hydration Level Assessment

  immediately, 24 hours & 7 days post surgery.

• Infection Evaluation

  24 hours & 7 days post surgery

Study Arms (2)

Placebo Laser

SHAM COMPARATOR

Placebo Laser is an inactive light

Device: Placebo Laser

Erchonia EML Laser

ACTIVE COMPARATOR

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

Device: Erchonia(R) EML Laser

Interventions

Erchonia(R) EML Laser DEVICE

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

Erchonia EML Laser

Placebo Laser DEVICE

Inactive light

Placebo Laser

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Erchonia Corporation: lead

Related Links

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

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Elvira Walls, Clinical Consultant
• Organization: Regulatory Insight, Inc.

elvira@reginsight.com

615-712-9743

Study Officials

• Robert F Jackson, MD, FACS

  PRINCIPAL INVESTIGATOR

• Gregory Roche, DO

  PRINCIPAL INVESTIGATOR

• Thomas L Jackson, MD

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2009
• First Posted: June 24, 2009
• Study Start: September 1, 2005
• Primary Completion: July 1, 2007
• Study Completion: July 1, 2007
• Last Updated: April 17, 2014
• Results First Posted: July 6, 2011

Record last verified: 2014-04