Breast Augmentation, Breast Reconstruction
Conditions
Keywords
Mentor BodyLogic TM System, Breast augmentation, Breast implant choice, Reoperation rates
Brief summary
At a national level of 15%, the reoperation rate following augmentation mammaplasty is too high. We are conducting a survey to examine the pre-operative methods by which plastic surgeons determine implant volume, size, shape and location; and to determine if the Mentor BodyLogicTM System can successfully improve outcomes. We will evaluate how measurements taken using BodyLogicTM influence choice of implant and whether there are any re-operations, particularly for size change. We hypothesize that using this system will help surgeons choose appropriate implants that will decrease the rate of reoperations, especially for size change.
Detailed description
We are planning to survey 10 high volume plastic surgeons that perform at least 10 breast augmentations a month and to collect data on at least 300 patients. The enrollment period will be 3 months. As part of this study, we are having the following steps performed: 1. Complete a 'general preference questionnaire', designed to document current preoperative planning and assessment methods for breast augmentation. 2. For each study patient, a pre-operative BodyLogicTM worksheet will be completed. Then, using the provided Implant Selection Booklet, the actual implant will be selected. The surgeon will maintain a key of the patients, and will identify them to the investigators only by subject number, and return these forms in provided stamped, self-addressed envelopes. 3. The patient returns at 1-3 months and 8-12 months for completion of the respective Body-Logic post-operative worksheets for each visit and the surgeon will send us the data in the provided envelopes periodically. 4. If during the course of the data collection, the surgeon has to re-operate on any patient, he/she will fill the re-operative form and send it to us. 5. Finally, the surgeon will complete a post-study evaluation questionnaire to help us understand how the BodyLogicTM System worked for him/her and how it could be improved.
Interventions
None listed
Sponsors
Mentor Worldwide, LLC
University of Minnesota
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Female (age \> 22 years) * Cosmetic Breast Augmentation only * Primary breast augmentation
Exclusion criteria
* Breast reconstruction * Secondary breast augmentation * \<22 years of age
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reoperation Rates | 2 years | Surgeon completed survey |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction With Outcome | 1 Year | Patient completed a survey regarding outcome |
| Surgeon Satisfaction With Outcome | 1 Year | Patient completedsurvey regarding outcome |
Countries
United States
Participant flow
Recruitment details
Surgeons recruited their own patients in their own offices
Pre-assignment details
as above.
Participants by arm
| Arm | Count |
|---|---|
| Total Population All surgical patients | 142 |
| Total | 142 |
Baseline characteristics
| Characteristic | Total Population |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 142 Participants |
| Sex: Female, Male Female | 142 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 142 |
| serious Total, serious adverse events | 0 / 142 |
Outcome results
Primary
Reoperation Rates
Surgeon completed survey
Time frame: 2 years
Population: All patients who were treated in the time period
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Total Population | Reoperation Rates | 6 participants |
Secondary
Patient Satisfaction With Outcome
Patient completed a survey regarding outcome
Time frame: 1 Year
Secondary
Surgeon Satisfaction With Outcome
Patient completedsurvey regarding outcome
Time frame: 1 Year