Low Level Laser Therapy to Reduce Pain After Breast Augmentation Surgery
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|ClinicalTrials.gov Identifier: NCT00926887|
Recruitment Status : Completed
First Posted : June 24, 2009
Results First Posted : July 6, 2011
Last Update Posted : April 17, 2014
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|Condition or disease||Intervention/treatment||Phase|
|Pain||Device: Erchonia(R) EML Laser Device: Placebo Laser||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||104 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||A Double-Blind, Randomized, Placebo-Controlled Evaluation of the Effect of the Erchonia(R) EML Laser on Reducing Pain Following Breast Augmentation Surgery|
|Study Start Date :||September 2005|
|Actual Primary Completion Date :||July 2007|
|Actual Study Completion Date :||July 2007|
Sham Comparator: Placebo Laser
Placebo Laser is an inactive light
Device: Placebo Laser
Active Comparator: 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.
Device: Erchonia(R) EML Laser
Low level laser red light of 635 nm and delivering 1.5 joules/cm2.
- Number of Participants Who Scored Less Than 30 on the 0-100 Visual Analog Scale (VAS)for Pain 24 Hours Post-operative. [ Time Frame: 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.
- Self-reported Pain Rating on the 0-100 VAS 24 Hours Post-operative. [ Time Frame: 24 hours ]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.'
- Swelling Evaluation Through Length by Width Breast Diameter Measurements [ Time Frame: immediately, 24 hours & 7 days post surgery ]
- Self-reported Degree of Pain Rating in the Breasts Area. [ Time Frame: 24 hours, 7 days, 14 days & 28 days post surgery ]
- Use of Pain Management Medication Post-surgically. [ Time Frame: Through the 1st 7 post-operative days. ]Average number of rescue pain medication doses consumed across the 1st 7 post-operative days.
- Hydration Level Assessment [ Time Frame: immediately, 24 hours & 7 days post surgery. ]
- Infection Evaluation [ Time Frame: 24 hours & 7 days post surgery ]
- Wound Healing Evaluation According to the Modified Hollander Cosmesis Scale [ Time Frame: 7 days post surgery ]
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|Ages Eligible for Study:||18 Years to 55 Years (Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||Yes|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00926887
|Principal Investigator:||Robert F Jackson, MD, FACS|
|Principal Investigator:||Gregory Roche, DO|
|Principal Investigator:||Thomas L Jackson, MD|
|Responsible Party:||Erchonia Corporation|
|Other Study ID Numbers:||
|First Posted:||June 24, 2009 Key Record Dates|
|Results First Posted:||July 6, 2011|
|Last Update Posted:||April 17, 2014|
|Last Verified:||April 2014|