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The Aesthetic Surgery Education and Research Foundation

Award Winners and Funded Projects
A Randomized Placebo-Controlled Trial Evaluating Radiofrequency and Hybrid Fractional Laser for Vaginal Rejuvenation Print

The ASERF Scientific Research Committee and Board of Directors are pleased to announce the following grant award:

Researcher: Jeffrey Kenkel, MD

Grant Award: ASERF Interim Grant

Amount Awarded: $159,574

Project Name: A Randomized Placebo-Controlled Trial Evaluating Radiofrequency and Hybrid Fractional Laser for Vaginal Rejuvenation

Project Summary: Recently there has been an explosion of new minimally invasive technologies for the management of postmenopausal vulvovaginal symptoms, vaginal wall laxity, sexual dysfunction, and even mild to moderate urinary incontinence with very limited scientific studies to back the merits of these technologies and their claims.

This is a single-center, randomized, prospective study designed to evaluate the efficacy of radiofrequency and hybrid fractional laser for vaginal rejuvenation.  100 subjects will undergo a three-part treatment of the vulvovaginal area IntraGen RF unit, IntraGen RF unit placebo, DiVa HFL unit, or DiVa HFL unit placebo.  These treatments will be spaced one month apart and last about 25 minutes each.  Each subject will be screened, undergo testing at baseline, and will be followed conservatively with no further therapy until they reach 6 months after the initiation of the designated treatment. At that time, all subjects will undergo subjective and objective testing. Those in the treatment group will be followed to 9 and 12 months after the initiation of treatment with appropriate analysis. Those in the placebo group will have completed the study at this time and will be provided treatment, should they choose.  The primary outcome measure is improvement in vulvovaginal symptoms measured by the validated Vulvovaginal Symptoms Questionnaire.  Data obtained from each investigation will be recorded in a password-protected digital spreadsheet, and descriptive statistics will be obtained.

We will prospectively study one-hundred consecutive subjects who will be visiting the Plastic Surgery Clinic at the Outpatient Surgery Center for consultation, pre-operative, post-operative, skin care treatment, massage treatments, and miscellaneous visits, or are an employee of the study site (including faculty and residents) or are a UT Southwestern student or trainee (includes medical students or fellows), or are a normal healthy volunteer.  Volunteers will be solicited via word of mouth, flyers, the Center Times, Campus Update emails, and/or the Volunteer Research Participant Registry.

The purpose of the study and specific inclusion and exclusion criteria and potential risks/benefits will be discussed with the potential study subject.  All interested subjects will be given the Consent Form with adequate time for review.  The Investigator and/or his designee will address questions and concerns raised by the subject.  Those subjects who elect to participate will sign the Consent Forms prior to any study procedures.

 
Biofilms and Breast Implants – Scientific Guidance to Prevention and Treatment Print

The ASERF Scientific Research Committee and Board of Directors are pleased to announce the following grant award:

Researcher: William P. Adams, Jr., MD

Grant Award: ASERF Interim Grant

Amount Awarded: $ 45,300

Project Name: Biofilms and Breast Implants – Scientific Guidance to Prevention and Treatment

Project Summary: Breast implant based procedures remains one of the most popular cosmetic procedures performed by plastic surgeons. For the past 20 years, we have previously studied and described methods to optimize breast pocket irrigation. In a recent preliminary ASERF study (submitted to ASJ) we studied the in vitro efficacy of different irrigating agents on planktonic bacteria.  In the past 10 years the morbidity of biofilm mediated implant  infection has become front and center, particularly with the evolving story related to the pathogenesis of breast implant associated anaplastic large cell lymphoma. 

The efficacy of popular clinical agents is not well studied nor understood, specifically as they pertain to their effect on biofilm, and when an anti-biofilm effect outweighs anti-planktonic activity. The critical knowledge gap is how to not only prev

The purpose of this study is:

1. Scientifically evaluate different breast implant irrigating agents specifically for biofilm prevention

2. Evaluate the same agents for established biofilm eradication

 
New Innovation For Projected Flap Design Print

The ASERF Scientific Research Committee and Board of Directors are pleased to announce the following grant award:

Researcher: Ross Sayadi, MD

Grant Award: ASERF Interim Grant

Amount Awarded: $6,670

Project Name: New Innovation For Projected Flap Design

Project Summary: Markings for planning incisions in plastic and reconstructive surgery are most commonly drawn free-hand and to the surgeon’s best estimate, leading to potential mistakes that can lead to increased procedure time and patient risk. We believe that using a projector to project images of prefabricated surgical markings will serve as a more effective method for surgical planning.

We aim to create a mobile application compatible with smart devices like the iPad, iPhone, or Android phones and tablets that will contain a database of existing designs for flap reconstruction. In addition, we plan on overlaying each flap on a thermal camera image of the local blood supply.

Surgeons will be able to choose a prefabricated flap and customize the parameters to a particular patient using touch technology on a smart device. The wireless image projector will then project the flap and thermal blood supply from the smart device onto the patient to serve as a template for efficient and reliable incision planning. Additionally, this technology can also serve as an educational tool for residents allowing them to gain mastery drawing flaps.

It is hypothesized that planning surgical incisions can be made more precise and reliable by using a projected image as a template for surgeons to draw markings.

 
Genomic Profiling to Understand the Pathogenesis of BIA-ALCL Print

The ASERF Scientific Research Committee and Board of Directors are pleased to announce the following grant award:

Researcher: Nandu Nair, MD

Grant Award: ASERF Interim Grant

Amount Awarded: $10,000

Project Name: Genomic Profiling to Understand the Pathogenesis of BIA-ALCL

Project Summary:
Hypothesis: We hypothesize that micro and nano-silica nanoparticles with polyurethane may differentially affect the induction of new biomarkers that can potentially influence the pathogenesis of BIA-ALCL. Accordingly, we propose following specific aim:  

Specific Aim: To study the comparative effect of nano, micro, and macro silica gel in combination with the polyurethane on global mRNA profiling in T-Cell. Hypothesis: a) silica and polyurethane is the basic implant materials; b) comparison of different sizes will reveal their physiological implications; c) The mRNA profiling will reveal novel yet unidentified molecular factors associated with the implant materials; d) identification of novel molecular markers specific to implant constituents may lead to better treatment approach in BIA-ALCL.

Significance: Currently more than 11 million women worldwide have breast implants and this number is continuously increasing. Recent reports of BIA-ALCL can be a significant health concern for women with implants. As such, examination of the molecular basis of BIA-ALCL may reveal specific biomarkers leading to better therapeutic approach.

 
Optimizing Breast Pocket Irrigation 3.0 2016 Print

The ASERF Scientific Research Committee and Board of Directors are pleased to announce the following grant award:

Researcher: Eric Culbertson, MD

Grant Award: ASERF Interim Grant

Amount Awarded: $3,953

Project Name: Optimizing Breast Pocket Irrigation 3.0 2016

Project Summary: Breast augmentation is the most commonly performed surgical cosmetic procedure in the United States and the world. The role of bacteria/biofilm on breast implant surfaces in potentiating the development of capsular contracture, one of the most common complications of breast augmentation, has been well established. Interestingly, there is strong data that chronic inflammation from bacteria/ biofilm is also responsible for the development of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). A higher burden of implant bacteria/biofilm is associated with greater lymphocyte stimulation, specifically a T-cell response. Chronic T-cell activation in response to the implant biofilm may be the inciting factor in BIA-ALCL. We have previously developed and demonstrated the efficacy of specific antibiotic irrigation solutions against bacteria commonly implicated implant infection, to be used at the time of implant placement. However, certain bacterial species known to cause implant infection and/or biofilm formation have not been tested, particularly gram negatives, and Ralstonia spp have recently been linked to BIA-ALCL. The purpose of this study is to compare the in vitro efficacy of povidone-iodine, two previously studied triple antibiotic solutions and three new antibiotic solutions against previously untested bacteria implicated in implant biofilm formation and/or linked to BIA-ALCL.

 
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