Clinical Trials Logo

Clinical Trial 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 "BodyLogic"TM System can successfully improve outcomes. We will evaluate how measurements taken using "BodyLogic"TM 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.


Clinical Trial 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 "BodyLogic"TM 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 "BodyLogic"TM System worked for him/her and how it could be improved. ;


Study Design

Time Perspective: Prospective


Related Conditions & MeSH terms


NCT number NCT00684749
Study type Observational
Source University of Minnesota - Clinical and Translational Science Institute
Contact
Status Completed
Phase N/A
Start date May 2008
Completion date December 2010

See also
  Status Clinical Trial Phase
Recruiting NCT03757793 - Near-infrared Spectroscopy for Monitoring Tissue Oxygenation in Breast Reconstruction
Completed NCT05491473 - Negative Pressure in PAP Donor Sites
Not yet recruiting NCT06013514 - Post-market Prospective Clinical Study of Nagor Perle Mammary Implants
Completed NCT02169011 - Secondary Breast Reconstruction With a Flap of Skin From the Back N/A
Completed NCT01216319 - Evaluation of the Cook Biodesign Plastic Surgery Matrix N/A
Not yet recruiting NCT00973544 - Do Closed Suction Drains Affect the Complications Rate of Breast Reconstruction With Silicone Prosthesis? N/A
Completed NCT01176786 - Reusable Versus Disposable Draping System in Breast Reconstruction Surgery N/A
Active, not recruiting NCT00748722 - Pre-Operative Imaging of Abdominal Wall Perforators Using CT Angiography N/A
Completed NCT00753922 - Core Gel Study of the Safety and Effectiveness of Mentor Round Low Bleed Silicone Gel-filled Mammary Prostheses Phase 3
Completed NCT05897463 - Nipple Neurotization
Recruiting NCT05377723 - Abdominal Scar Improvement in Microsurgical Breast Reconstruction N/A
Completed NCT04350411 - Comparison of PEAK PlasmaBladeā„¢ to Conventional Diathermy in Abdominal Based Free Flap Breast Reconstruction N/A
Completed NCT06321549 - New Era of DIEP With Minimally Invasive Mastectomy
Withdrawn NCT03135392 - Sensation After Nipple Sparing Mastectomy and Breast Reconstruction With or Without Neurotized Free Tissue Transfer N/A
Completed NCT01256502 - The SERI® Surgical Scaffold Use in Reconstruction Post Market Study for Tissue Support and Repair in Breast Reconstruction Surgery N/A
Active, not recruiting NCT04715802 - Options on the Breast Reconstruction Timing and Method After Removal of Polyacrylamide Hydrogel
Active, not recruiting NCT04491591 - Implementing BREASTChoice Into Practice N/A
Recruiting NCT04661501 - BREAST ADM Trial for Alloplastic Breast Reconstruction N/A
Suspended NCT03625765 - Integrated Imaging System for In Vivo Visualization of Free Flap Perfusion Using Indocyanine Dye N/A
Withdrawn NCT00778947 - Single Centre Study to Compare Harmonic Scalpel to Conventional Diathermy in Free Tissue Transfer Breast Reconstruction N/A