PSEF foundation

Message from the President

Dear Fellow ASPS Member,

The Plastic Surgery Educational Foundation (PSEF) is very excited about the launch of our new e-newsletter foundation and we very much hope that you will find it informative and useful. As you are aware, over the past couple of years we have made some dramatic changes to the governance, structure and function of the PSEF. We have renewed our focus on research and put our money where our mouth is by increasing research funding. We doubled our research investment last year. What's more, we have sought input from across the specialty to identify clinically relevant questions to research. We are currently funding projects to provide the answers to these questions that will have a tangible impact on your practice. We are working to develop a vibrant, specialty-wide research program and as such we have established a clinical trials network so we may have the facility to answer clinically relevant questions and power these studies to be meaningful. Research not only facilitates the development of new techniques and approaches, it also gives us very useful benchmarking information on how well we are doing and what our outcomes are like. This is very powerful information that may help position us in a very favorable light when we are compared to other specialties that, oftentimes, have encroached on our area of practice and claim to do it well. Armed with data, not only can we claim that we do something well, we can prove it.

Apart from what we think of as conventional research, many advances are also made through technical innovation. The history of Plastic Surgery has been one rich with innovation. Innovation is a continuous process of change. This newsletter exists to keep you informed of these changes as they happen and the impact they have on your practice. foundation will seek to provide you with information on what's new and hot in research, what advances are being made clinically in different areas, what new innovations are happening and who are the people making these changes. We have many success stories within our specialty and this e-newsletter offers a forum for celebrating these success stories.

We live in exciting times. The field of tissue engineering has progressed to the stage where we are starting to see innovative products appear on the market place, the field of composite tissue allotransplantation is about to explode and we are using new and more sophisticated imaging systems to plan our surgeries. We hope that this newsletter will keep you abreast of these changes as they happen. As I said at the outset, we are very excited to offer you foundation and we look forward to hearing your feedback.

Sincerely,

Peter C. Neligan Signature

Peter C. Neligan, MD

PSEF President

PSEF National Endowment Grant award winner

Breast reconstruction research targets implantable dermal matrix

The Researcher
Colleen McCarthy, MD

Title: Reconstructive Surgeon at Memorial Sloan-Kettering Cancer Center, New York

Project: "The Use of AlloDerm® in Two-Stage, Tissue Expander/Implant Reconstruction"

What is the aim of your project?

Dr. McCarthy: Our group has set out to rigorously evaluate the effect of AlloDerm - an implantable dermal matrix manufactured by LifeCell Corporation in Branchville, N.J. - in the setting of tissue expander/implant breast reconstruction. To this end, we have designed a multicenter, single-blind, randomized controlled trial. In total, eight investigators across three centers are involved.

We are specifically looking to see if AlloDerm has any effect on the tissue-expansion process and on patient-reported postoperative pain. We're also interested in longer-term outcomes such as the development of capsular contracture and patients' overall aesthetic results. Finally - and perhaps most importantly - we are interested in determining how AlloDerm impacts patient satisfaction with regard to both the process and the outcome of tissue expander/implant reconstruction.

We are really excited about this trial. The high cost of AlloDerm and the lack of high-level evidence regarding its safety and efficacy in post-mastectomy reconstruction underscores the need to critically evaluate its use. In addition, we must ensure that new techniques or materials do not replace traditional techniques simply for reasons of novelty or peer pressure.

By randomizing patients to undergo TE/I reconstruction with or without the use of AlloDerm, we will be able to determine whether a cause-effect relationship truly exists between AlloDerm and its reported benefits.

At what stage are you currently?

Dr. McCarthy: Recruitment is well underway at three sites: Memorial Sloan-Kettering Cancer Center, the University of Michigan in Ann Arbor and the University of North Carolina in Raleigh.

What do you hope will come of your research in practical terms?

Dr. McCarthy: We believe that our efforts will not only afford us the opportunity to provide optimal care to patients, but will also allow us to demonstrate to health care payors that our surgical practice is based on high-quality evidence rather than on consensus or commonality of practice.

Once you've met these current grant goals, where do you go from there with your overall research model?

Dr. McCarthy: That will depend to a large extent on what we discover from the trial. For example, if we demonstrate that AlloDerm can provide significant benefits for patients in the tissue expander/ implant reconstruction setting, we will look to evaluate the cost- effectiveness of its use.

How has the PSEF grant affected - or how do you expect it to affect - obtaining funding from other sources?

Dr. McCarthy: Perhaps one of the biggest challenges we were up against in designing this multicenter, randomized clinical trail was the cost of such a study. PSEF support was critical to our pursuit of this endeavor.

How has the research affected other investigators in your field? Has the PSEF funding helped to attract other collaborators from within plastic surgery - or from outside of our discipline?

Dr. McCarthy: PSEF funding certainly helped facilitate collaboration among the three study centers. By being able to involve eight surgeons at three different centers, the generalizability of our study results will be magnified - which will add significant strength to the study.

How research impacts my practice

PSEF with Brian Kinney, MD

How does research and data influence the way you practice?

Dr. Kinney: Research is the window into the future and predicts practice patterns 3-5 years in advance. An example from today which influences my practice includes understanding fat metabolism via rigorous clinical trials in mesotherapy and stem cells. Another is composite tissue allografting in the laboratory, immunology and face transplants.

What areas of research are you currently following?

Dr. Kinney: Having performed more than five FDA clinical trials for hyaluronic acid injectables, I am keenly following this area of research. This is an opportunity to bring Level I evidence to the world of aesthetic surgery. The turnaround time for introducing new results into clinical practice is often less than two years, and has immediate patient impact upon introduction. Similar efforts would include the understanding of wound healing from topical skin therapies like those investigated in the Obagi project.

Essentially all of plastic surgery is influenced by the rapidly developing field of bringing objective scientific evidence to aesthetic surgery via validated outcome vehicles like the BREAST-Q (for quality of life). This has tremendous potential impact in the FDA process where the challenge has been to document the improvement that patients experience from breast implants. The burden of tracking tens of thousands of patient for implant rupture is a critical effort to one of the most visible and controversial issues in regulation of medical devices.

How have you used this new information in your practice?

Dr. Kinney: Scientific data on hyaluronic acid clinical trials directly guides the choice of various injectables and improves results, patient satisfaction and safety. Knowing which chemical properties are advantageous in a particular anatomic region is invaluable.

Patient reported outcomes in my FDA clinical trials of hyaluronic acid injectables in the nasolabial folds have specifically guided my counseling of future patients about duration, effectiveness of correction, and complications, such as nodules, bruising, bleeding, and asymmetry. In addition, results from the chemistry studies guide my off label use in the tear trough, Periorbitum, and chin.

What would you like to see done in research to further your practice?

Dr. Kinney: My practice would be improved by research that involves stem cells, energy devices (laser, radio frequency, ultrasound, sound, etc), fat and cellulite. Grafting and transplantation basic science, metabolism and tissue injury remain core to plastic surgery practice in reconstruction and cosmetic procedures.

What would other Plastic Surgeons be surprised to know about research and how data driven research can improve their practice?

Dr. Kinney: Perhaps the biggest surprise, hidden in plain sight, is that basic science and reconstructive research are the building blocks and prognosticators of aesthetic procedures, whether for face lift, breast implants or reduction, fat metabolism, wound healing, skin and soft tissue augmentation, tissue regeneration or others.

Where do you look to find your research information?

Dr. Kinney: I routinely follow basic science, engineering, and the chemistry literature for metabolism, wound healing; implants, energy devices and new surgical equipment; and injectables. In addition, I attend conferences outside of our specialty, and sometimes outside of medicine. The PSEF and the National Endowment are the best sources for guidelines on trends in plastic surgery research and emerging trends in clinical practice.

Helping hands of the past lead plastic surgeon to the Maliniac Circle

By Jim Leonardo

Karol Gutowski, MD, Chicago, Ill., has witnessed firsthand how one philanthropic act can sprout countless others. He says the help his parents received upon their arrival to the United States from eastern Europe has been etched into his memory and guides his outlook on life and charity.

"I came from Poland in 1971 with my parents, who didn't have much when they emigrated," says Dr. Gutowski, chief, plastic surgery division, NorthShore University Health System. "They were approaching middle age when they came here and had to make a living from scratch. Some people helped them as they worked their way up, and when my parents were finally established they gave what they could to others who needed help.

"My parents also invited people to come to the United States and helped them get set up," he adds. "That was one of the best examples of 'giving begets giving' that I ever saw - once you get established, you pass along whatever you can to the next group that needs it."

The experience formed Dr. Gutowski's philanthropic philosophy, which led to his induction into the Maliniac Circle during Plastic Surgery 2005 in Chicago. The Maliniac Circle is reserved for plastic surgeons who have contributed or will contribute to the National Endowment for Plastic Surgery at least $100,000 through estate bequests or life insurance policies, or $50,000 in cash or securities. Dr. Gutowski and his wife, Ellen, chose the life insurance option.

"I've benefited from assistance at critical points in my career as well, and now I'm in a position to return that support," Dr. Gutowski says. "I do that gladly."

Family ties

Ellen Gutowski came to America from the former Republic of Yugoslavia - now the Republic of Croatia - at age 2, and she and her parents also received critical assistance from family members. "Her uncle invited her parents to come here and he helped them out," Dr. Gutowski says. "She also understands that without other people doing the work beforehand - in this case, her uncle establishing himself first - it would be hard for the people who come here to move forward.

Dr. Gutowski views the endowment as being among the most important vehicles to which plastic surgeons can contribute - on multiple levels. "In addition to funding significant research, a contribution to the endowment also makes a statement," he says. "If others see you contribute, they may follow with their own contribution - and the endowment will build that much more quickly."

Following in footsteps of others

Dr. Gutowski says he also found role models in a number of ASPS leaders he's watched give back to the specialty in various and sundry ways. He counts ASPS immediate-past President Bruce Cunningham, MD, Minneapolis, as one of those who left a strong impression. "I worked in his lab at the University of Minnesota 10 years ago and saw how active he was in assisting others," Dr. Gutowski says. "I also trained with ASPS past president Rod Rohrich, MD, Dallas. He also was involved in giving back at a high level. Through them and others, I saw the importance of being active on the national and local levels. "

Setting the record straight

Though contributions to the endowment cannot be targeted to a specific research activity, Dr. Gutowski would like to see his donation fund vehicles designed to study and measure plastic surgery outcomes. "I would like an emphasis on demonstrating that plastic surgeons' work does make a difference," he says. "For instance, because of plastic surgery people have been able to retain damaged limbs that, in the past, would have been amputated. As a result, these patients can again contribute to society."

He says that plastic surgery quality measurements also would change the largely simplistic view of the specialty held by some politicians and the public that results from reality TV's focus on the sensational. "They don't see the reconstructive side unless they or someone they know has been through it," Dr. Gutowski says. "Therefore, it's become important to demonstrate that many of the procedures plastic surgeons perform truly change lives."

While all Maliniac Circle inductees have their own motivation for contributing, Dr. Gutowski maintains that plastic surgeons who haven't contributed should look at it as an investment in the future, with the end result being better treatment. "We invest for our children's education and for retirement; this is an investment in our specialty's future," he says.

"Supporting the National Endowment can yield new treatment options and better ways of doing things that will keep plastic surgery at the forefront of clinical care, as opposed to taking a back seat and copying from other specialties," Dr. Gutowski says. "That, in turn, will help patients. Is there any greater motivation?"

Where are they now: PSEF and V. Leroy Young, MD

Investigator: Leroy Young, MD V. Leroy Young, MD
Award: 1993 PSEF Research Grant Award
Project Title: Chemical Analysis of the Contents of Saline-Filled Breast Implants
Institution: Washington University School of Medicine in St. Louis

Dr. Young left Washington University in mid-2002 to form a private practice, BodyAesthetic Plastic Surgery & Skincare Center. Most of the research conducted with PSEF grants was based in the Washington University Department of Mechanical Engineering.

When did you receive your first PSEF award and what was the focus of your project?

Dr. Young: My first PSEF-sponsored research grant was awarded in 1993 and co-funded by what was then McGhan Medical (now Allergan). The project was titled "Chemical Analysis of the Contents of Saline-Filled Breast Implants." The study showed that the elastomer shells of breast implants are not impermeable and explanted saline-filled implants typically contain substances that diffused through the shell from the surrounding tissues. Since this project, I have been fortunate to have 7 other research projects funded (in whole or in part) by PSEF. All of these studies were designed after the 1992 moratorium on the use of silicone gel implants for breast augmentation, and all were directed at increasing our understanding of how, when, and why these devices fail over time. Titles of studies funded by PSEF are:

• Biomechanical Analysis of Explanted Breast Implants (1994)
• Breast Implant Durability and Rupture Characteristics (1997)
• Pilot Study to Determine the Rate of Silicone Gel Breast Implant Failure Using MRI (1997)
• Failure Mechanisms of Breast Implants (1999)
• Betadine Pocket Irrigation and the Subsequent Effects on the Integrity of Saline Breast Implants (2000)
• Center for Implant Retrieval and Analysis (2000-2002)
• Chemical Analysis of Silicone Gel Implant Components in Capsule Tissue (2004)

My research funding from PSEF began small, at a time when a typical grant totaled $5,000. Much of the work from the 1990s led to establishment in 2000 of the Center for Implant Retrieval and Analysis, which was funded by PSEF through a National Endowment for Plastic Surgery grant, as well as ASERF. The Center consisted of a multi-disciplinary team of engineers, chemists, geologists, and myself as we analyzed the material and chemical properties of breast implants, including tensile strength, elongation, tear resistance, breaking energy, abrasion resistance, and crosslink density of elastomer. Some of our work focused on determining the mechanical and physical properties of implants that had been removed (explants) and comparing them with lot-matched controls that were never implanted. Plastic surgeons from around the country helped greatly by sending us explants made between the 1960s and 1992 by all the device manufacturers, which helped the Center build the largest inventory of explanted 1st, 2nd and 3rd generation breast implants in the U.S. The protocol for testing implants developed by the Center was later endorsed and advocated by the Food and Drug Administration.

Since you've received your PSEF award, what significant scientific findings have you made in your continued efforts?

Dr. Young: The work of the Center for Implant Retrieval and Analysis and its personnel led (directly or indirectly) to the publication of at least 29 articles in peer-reviewed journals and more presentations at national and regional meetings than I can remember. I think the projects funded by PSEF made an important contribution to understanding the mechanisms of saline and silicone gel breast implant failure. For instance, we learned that the material properties of implant shells do not "degrade" over time, but the elastomer does become fatigued, as does any material subjected to wear. Our examinations of experimental and explanted implants with scanning electron microscopy allowed us to characterize failure mechanisms of these devices, including stress exerted on an implant during its insertion, sharp instrument damage at implantation or revision, and shell fatigue generated by folding and unfolding of the shell, which leads to abrasion until the material tears. Fatigue at the junction of the shell and patch is another failure mechanism. These and other findings of the Center played a role in the FDA's 2007 approval of silicone gel breast implants.

What are you working on now?

Dr. Young: Recently, much of my attention has been focused on building awareness of the need to improve patient safety practices in plastic surgery. Breast implant research taught me that using a multidisciplinary approach is often the best way to conduct research. Going outside the specialty of plastic surgery is especially critical for patient safety efforts because reducing surgical complications requires working with infection control specialists, hematologists, epidemiologists, anesthesiologists, endocrinologists, internists, and psychologists. To put it another way, plastic surgeons need to ask colleagues for help. When I decided to write/edit the recently-published book called Patient Safety in Plastic Surgery I knew many of the chapters should be written by these types of specialists, and my co-editor is an anesthesiologist. My interest in patient safety has led to retrospective and prospective studies that are investigating the prevention of deep vein thrombosis and pulmonary embolism in plastic surgery patients. Other special interests include preventing hypothermia and surgical site infections, which have been topics of publications.
During the last 2 years I have been a principal investigator in 4 trials directed at improving the appearance of scars and keloids, some of the most difficult problems to solve in plastic surgery. Two additional studies of surgical and traumatic scar treatments are set to begin in the fall of 2009. We are also conducting the first controlled study of the safety and efficacy of injection lipolysis (using phosphatidylcholine and deoxycholate) that includes MRI scans and tissue biopsies of treated and untreated sides of the abdomen. Beginning this project required first spending 18 months working to gain FDA approval of an Investigational New Drug (IND) application, which was necessary before an Institutional Review Board (IRB) would approve the study. I'm also working as a sub-investigator on a project that is gathering data about the quality of life following body contouring surgery after weight loss procedures.

What applicability in today's world does your research have?

Dr. Young: I like to think that efforts to increase plastic surgeons' understanding of the importance of keeping our patients safe may save a life or prevent a serious complication. But this will require surgeons to adopt new approaches and protocols for patient care that are better aligned with national standards. Perhaps a majority of plastic surgeons will see no need to follow such guidelines until they are convinced to change what they've been doing for years. Change does not come easily. Although I believe the widespread adoption of improved safety measures will eventually happen, I hope it does not come at the expense of our patients. I am convinced that continuing basic and clinical studies on scarring may one day result in the ability to perform surgery that leaves little or no evidence of an incision. We have made some progress on preventing the recurrence of keloids after their removal, but I doubt we have the full answer yet. Furthermore, treatments for improving the appearance of surgical and traumatic scars that patients consider disfiguring are also within reach if basic and clinical research is continued.

What would you like to see the researchers of today/tomorrow do with your work?

Dr. Young: I hope other researchers might follow the example of looking outside their specialty to find expertise offered by other scientists. By definition, scientists are curious problem solvers who enjoy new challenges and have a passion for answering the research question. A large majority of plastic surgeons are not interested in research. Those who do want to pursue research can benefit greatly from groups like PSEF and the National Endowment, which can provide "seed money" to help fund research.
Start with a small idea that requires a small amount of funding and only minimal assistance from your staff. Learn how to identify a small research question and write a proposal that outlines a way to gain insight into the question. I am certain that my first PSEF proposal was poorly done, but the importance of the research question and a way to get an answer must have been evident. If you start small, you will likely end up with a presentation at a meeting of colleagues and perhaps a publication. This helps you to convince funding sources that you can complete the many tasks of a project. You then receive another small grant, present your findings and publish an article. Before long you are building a career and a reputation, at which point the grants get larger and additional funding sources are identified.
I was fortunate to find collaborators from the basic sciences who knew more about putting together a study proposal than I did. These colleagues taught me many of the basic principles behind designing and conducting a scientifically sound research study, which should always be the goal. Every project will have much to teach you about managing a study, its budget, and the personnel needed to help the project succeed.

What advice would you give someone just embarking on their research career?

Dr. Young: Most surgeons do not start their careers with wise mentors or the infrastructure needed to design and support research studies. Although I did not have a mentor nor the staff to conduct research, I was fortunate to begin my career at a highly-regarded university medical school, which probably played some role in attracting early funding. Even so, my participation in clinical trials primarily came after I left the university as I gradually gained expertise and surrounded myself with quality personnel who can help develop a study protocol, manage the multitude of small details, and organize the considerable paperwork associated with randomized clinical trials, including budgets, institutional review boards, patient scheduling, completion of case report forms, etc.

To help meet this challenge, my partner (C.B. Boswell) and I recently started the BodyAesthetic Research Center within our practice as a way of putting together an infrastructure of people and processes that can support clinical trials without the overhead costs and bureaucracy associated with medical schools. Drug and device manufacturers who are working to gain approval from the FDA are attracted to the advantages we offer, although these types of studies mean greater complexity and responsibility. At the same time, large randomized studies, which may involve multiple study sites, are more likely to produce Level 1 evidence that best defines whether a specific treatment or approach to a patient produces a better surgical outcome or reduces complications. The funding received from sponsored clinical trials can help support other unfunded research that also looks for answers to important questions.

For surgeons who are interested in pursuing research, the importance of staying current cannot be emphasized too much. By following the literature and becoming more active with organizations like PSEF, you will be better able to identify research needs and possible funding sources. In some instances, surgeons new to research may feel most comfortable confirming or refuting the findings of another study, and such work is very important. As experience and confidence grow, researchers should begin to think outside the box. Ask a different research question, study a modification of a technique, approach a problem with the help of specialists outside plastic surgery who will bring a different perspective. Finally, keep your mind open so you'll recognize when something could be accomplished, or prevented, in a better way.

Did you enjoy this issue of foundation? We would like to hear about it! Please direct your comments and inquiries to us at research@plasticsurgery.org.

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