Treatment target
Research efforts target innovative therapies for wound healing, cosmetic procedures

Bill Gillette
Staff Correspondent

WASHINGTON — The Department of Defense recently awarded a multi-million-dollar research grant to develop new therapies for wounded soldiers, which may hasten the pace at which unique, innovative burn- and wound-healing and cosmetic procedures become commonly used by plastic surgeons for treating civilians.

“Much of the research is related to the specialty of plastic surgery.

Millions for Medicine
The DOD recently announced that $85 million in research funding was being given to the Armed Forces Institute of Regenerative Medicine (AFIRM), a network of plastic surgeons and other physicians who specialize in tissue engineering and regenerative medicine. The funding will be distributed over a five-year period. About 25 percent of AFIRM’s physician researchers are board-certified plastic surgeons; other specialties represented in AFIRM include dermatology, general surgery, orthopedics and otolaryngology.

The $85 million grant has been evenly split between the two civilian research consortia that comprise AFIRM and which will work with the Army Institute of Surgical Research to develop new therapies for treating U.S. soldiers wounded in Iraq and Afghanistan. One consortium is led by the Wake Forest Institute for Regenerative Medicine and the University of Pittsburgh’s McGowan Institute for Regenerative Medicine; the other consortium is headed by the New Jersey Center for Biomaterials at Rutgers University and the Cleveland Clinic’s National Center for Regenerative Medicine. A total of 28 universities and medical-research institutions are involved.

The AFIRM effort is aimed at speeding the delivery of regenerative-medicine therapies to soldiers who’ve been critically wounded in Iraq and Afghanistan, says Richard A. Clark, M.D., director of the Center of Tissue Engineering and professor of biomedical engineering at consortium member Stony Brook University on Long Island, NY. He says AFIRM is focused on five major research areas: salvage, reconstruction, regeneration and transplantation of limbs; craniofacial reconstruction; burn repair; scar reduction; and treatment for compartment syndrome.

Research Underway
“Much of the research activity funded by AFIRM is already under way at the individual participating institutions,” Dr. Clark tells Cosmetic Surgery Times. “For example, in a collaborative project with the Department of Emergency Medicine at Stony Brook, we are looking at ways to prevent burn-injury progression, and we will also be studying a peptide I discovered that is critical in connective-tissue cell survival and proliferation. It is our hope that our efforts eventually will help prevent burn-injury progression in patients whether they are wounded warriors or civilians.”

According to DOD statistics, as of mid-April, nearly 29,800 soldiers had been wounded in action in Iraq and another 1,927 in Afghanistan. Given the length of time these operations have been going on — as well as media coverage of inadequate treatment of Iraq and Afghanistan veterans — some might question why it’s taken so long to get this kind of research effort under way.

“I cannot comment on the timing other than to say that it’s never too late for innovative and ambitious thinking,” says Adam J. Katz, M.D., associate professor in the Department of Plastic Surgery at the University of Virginia, another consortium member. “The AFIRM grant is a completely new research paradigm in terms of structure, breadth and ambition. For me, it’s a genuine privilege to be a part of this effort.”

As for his research projects, Dr. Katz tell Cosmetic Surgery Times that they involve wound healing.

“We are initiating clinical trials to test the role of autologous fat transfer in the prevention and management of scars, and its potential to enhance healing of complex wounds, using controlled, blinded, randomized study designs,” he says. “The aim is to provide evidence-based methods, techniques and treatment guidelines for AFT.

“We also are focusing on the development and use of autologous adipose-derived, cell-based therapies and constructs for the repair, replacement and/or regeneration of the hypodermis, dermis and/or the epidermis.”

Partners in Care
According to Stony Brook’s Dr. Clark, many medical companies have expressed a willingness to work with the AFIRM consortia as partners.

“We are extremely pleased that the American medical-device industry has taken such a keen interest in speeding these important new therapies to market not just for injured service members, but for civilian patients as well,” he says. “We believe that this participation will ultimately lead to better health care options for all Americans.”

In addition to those mentioned above, the following institutions comprise the two AFIRM consortia: Carnegie Mellon University; Case Western Reserve University/University Hospitals Case Medical Center; Dartmouth Hitchcock Medical Center; Massachusetts General Hospital/Harvard Medical School; the Massachusetts Institute of Technology; the Mayo Clinic; Northwestern University; the University of Cincinnati; the University of Medicine and Dentistry of New Jersey; the University of Pennsylvania; Vanderbilt University; Baptist Medical Center; Allegheny Singer Research Institute; the California Institute of Technology; the Georgia Institute of Technology; Intercytex; the Oregon Medical Laser Center at Providence St. Vincent Medical Center; Organogenesis; the Pittsburgh Tissue Engineering Initiative; Rice University; Stanford University School of Medicine; Tufts University; the University of California, Santa Barbara; the University of Texas Health Science Center at Houston; the University of Wisconsin; and Vanderbilt University. CST

Practice pulse
Cosmetic surgeons weigh in on how the economy is – or isn’t – affecting their practice

Karen Nash
Staff Correspondent

While experts debate where the United States is on the slide toward, or down into, a recession, and gas prices rise, forcing up the cost of other necessary commodities, cosmetic surgeons are looking at what effect the economy is having, or could have, on their practices.

Cosmetic surgery, by definition, is not considered a necessity of life. But just as the experts can’t come to a common assessment of the country’s economic status, neither are cosmetic surgeons around the country experiencing the same effects on their practices.

Reported Discrepancies
Even cosmetic surgeons in Southern California don’t have identical experiences , according to Ron Moser, M.D., who practices in San Juan Capistrano.

“I don’t know if people are being honest, but everybody I talk to tells me something different. This is the worst I’ve seen it in the 20 years I’ve been in practice. Other doctors tell me this is the best it has been for them in 20 years.

“One of the odd things is that it seems the more expensive the doctor is, the busier he is. I know doctors charging $20,000 for a breast augmentation and they are booked solid.”

Because Dr. Moser’s practice initiated plastic surgery financing 20 years ago, it has historically targeted a different type of clientele — one that relies on financing — and, as a result, he’s had to find a different way to cope with the economy.

“The people who are attracted to financing are also attracted by marketing. They tend to be middle-to lower-middle class patients. That’s because the upper-middle class buyers find their surgeons from referrals not from the yellow pages or TV ads.

“We’ve lowered prices almost 40 percent just to do the same business we were doing a year or so ago. But even there we are seeing a change. People are trying to avoid financing procedures because everybody’s credit is shot around here.”

Midwest Measure
On the other hand, in Tulsa, Okla., not known for being a cosmetic surgery Mecca, Angelo Cuzalina, M.D., says the teetering economy has barely caused a blip on his screen.

“I’ve been fortunate. I think it’s being in Oklahoma, which is an oil state. Even when the overall economy of the Untied State is down, Oklahoma hasn’t been hit as hard. There is a certain percentage of the population in Oklahoma who make a lot of money when the price of oil goes up.

“Oklahoma, specifically, and the Midwest in general, have lower prices, and that could be a factor too. We have some of the lowest prices in the country — charging about half the price they charge in California. We are actually seeing more patients traveling here from other states including California and Arizona.”

Dr. Cuzalina has a new associate who has struggled because of the economic turndown, but the practice has taken action to address the problem.

“He is so early in his career that he felt like he was slowing down a little bit, so we increased our marketing efforts and it has picked up.”

Dr. Cuzalina has noticed a change in the procedures patients are choosing. “We are seeing fewer smaller procedures that are temporary, and bit of an increase in the larger, more permanent procedures. People don’t want to ‘waste’ money and have to keep coming back.”

Baby Steps
That experience is quite different than the situation in the practice of Gregory C. Roche, D.O., in Bloomfield Hills, Mich.

“The economy has definitely cut the number of people having elective cosmetic surgery by almost 50 percent here. It has also driven people down other avenues, where they are getting smaller procedures — procedures that are more like buying time.

“That sometimes works out nicely because people take more time to evaluate what they want. Then when the economy turns around, like it usually does, patients end up having those bigger procedures done.”

Although Dr. Roche began to experience effects of the slowing economy only in the past few months, he says it’s been affecting other practices in his community over the past couple of years because of the struggling automobile industry.

“There were severe cutbacks by car manufacturers and ancillary businesses, but there is hope. Although GM recently announced a loss for last year, Ford made a $100-million profit. Things have started picking up this spring — it’s not super busy, but busy enough that we can keep going.”

Dr. Roche says, without compromising quality, his office has been working to operate more cost efficiently, and has added new procedures such as SmartLipo to broaden his patient base.

Tweak Trend
In Boca Raton, Fla., a noted center for cosmetic surgery, Hilton Becker, M.D., says the economy is definitely affecting his practice.

“We’ve definitely seen a downturn in surgery, but we’ve seen an increase in nonsurgical procedures, such as injectables. People want to do something, but they don’t want to spend money for expensive surgery. We’ve been doing a lot more injectables than we’ve ever done in the past.

“I’m not certain if it’s the same patient that would have had a facelift before or if we’re developing a different patient base. It’s still too early to tell.”

Dr. Becker says there will be competition for that patient base. He’s seen more nonplastic surgeons picking up the injectables as a way to offset their dropping insurance reimbursements.

Clearing Skies?
In Hartford, Conn., Stephen A. Brown, M.D., sees the possibility of a break in the slowdown in surgery.

“It’s been interesting. Things got slow from early fall through January. Then things picked up in February — I have no idea why. It’s not like it was before, but it is improving.

“One interesting factor is that it’s not picking up among people who are wealthy. Quite the opposite. It’s picking up with hard-working people. All I can figure is that if they’re down a bit, they just decide they need a pick-me-up and decide to do something for themselves.”

Dr. Brown’s approach is multi-pronged. He hasn’t cut rates but only offers financing through Capital One because they vet the patients. And he’s upgraded his Web site.

“I have a wonderful guy running it after I dropped one of the big companies that charged a lot, but offered very little in service or results.”

He also hired a new office manager who, he says, is great at keeping the overhead in check.

His advice to other cosmetic surgeons? Remember the three As — availability, affability and ability.

“If you are really a truly caring person, and you’re willing to treat new patients well when they come in, you can lock in people who don’t get that treatment elsewhere.”

When fewer patients are spending less money, Dr. Brown says that’s a wise practice. CST

CO₂ combos
Carboxytherapy reported to provide adjunctive advantages with aesthetic treatments

John Jesitus
Senior Staff Correspondent

NEW YORK — Carboxytherapy delivers impressive results for cellulite, dark under-eye circles and stretch marks, says Marian Zilkha, M.D., Ph.D., a Brazilian-licensed ophthalmic plastic surgeon who coordinates aesthetic procedures at Manhattan's Integrated Center of Aesthetic Medicine. In Brazil and Europe, experts add, physicians use adjunctive carboxytherapy for everything from alopecia and anesthesia to pain management, psoriasis and wound healing.

Like many cosmetic treatments, Dr. Zilkha says, carboxytherapy works best in combinations. "Even with Botox (botulinum toxin A; Allergan, Irvine, Calif.,)" she explains, "one must add fillers and perhaps skin tightening devices for optimal results. Our menu of therapies is very vast today," and few treatments succeed solo.

The simplest combinations include carboxytherapy and skin care products such as retinoids. Carboxytherapy also works well with pulsed dye lasers or intense pulsed light, says Dr. Zilkha. "Stretch marks can be red or white, and carboxytherapy won't completely address the color component, although it tremendously improves overall skin quality, color and texture," she says. Stretch marks typically require five to eight treatments, she adds.

"RioBlush is the best treatment for stretch marks, a problem for which plastic surgeons normally have no effective solutions," says Sebastiano Montoneri, M.D., a plastic surgeon at Paris's Clinique Elysee Montaigne who also practices in Italy. The device helps to make the color and texture of scars and stretch marks more similar to that of the surrounding skin, thereby rendering them less noticeable, he says.

Dark Circles
To treat dark circles around the eyes, Dr. Zilkha uses intradermal injections, placed in the lower lid at the outside corner of the eye with a very fine needle. (Upper lids sometimes require injection as well, she says.) "Once the skin is lifted with a very small volume of gas — it takes two to four seconds maximum — you can remove the needle and treat the other eye," she explains.

In less than five minutes, "The gas is totally reabsorbed. The body recognizes the increase in CO₂, circulation to the area increases and hemoglobin transports it away. The increased blood flow stimulates collagen, which will soften fine wrinkles and decreases dark circles under the eye."

Patients start seeing results, including improved texture, fewer fine wrinkles and greater luminosity, after one or two sessions, according to Dr. Zilkha, although she usually recommends five or six treatments spaced weekly. The treatment works for all skin types, she adds, although she recommends one puncture per eyelid in Fitzpatrick skin types III and higher.

Additionally, she says that patients with small residual fat pockets under the eyes, mouth or chin notice an improvement after two to three CO₂ treatments. However, she cautions against performing carboxytherapy and injectable treatments such as Botox or fillers during the same visit because the flushing caused by CO₂ injections increases the chances of bruising.

For all types of treatments, adds Dr. Zilkha, "One of the big advantages of the RioBlush system is that the device has a built-in safety check: the tubes are totally drained of gas and oxygen prior to each treatment, when the device starts flowing." With some carboxytherapy systems, she says, physicians have been known to unintentionally inject air from within the tubing with the CO₂, causing residual eyelid distention that can last up to two days.

Creative Combinations
Overall, Dr. Zilkha says, "Carboxytherapy is still very new, and we're still learning more about it." However, its low morbidity allows physicians to continually fine-tune treatment protocols without placing patients at risk, she says.

As a result, international physicians have devised a host of creative combinations involving the RioBlush system.

"I normally use RioBlush in conjunction with mesotherapy, especially with hyaluronic acid (HA)," Dr. Montoneri says. RioBlush stimulates vascularization and neocollagenesis, and free-molecule HA (as opposed to the reticulated type used for dermal fillers) helps stabilize the new collagen, which improves aesthetic results, he says.

RioBlush also works very well for facial and neck rejuvenation, says Dr. Montoneri. "In these areas,” he says, "It improves the skin quality and reduces the small wrinkles that normally we're not able to treat with a facelift."

Because RioBlush improves tissue oxygenation and vascularity, Dr. Montoneri adds, he frequently uses this treatment before surgical procedures such as rhytidectomies. It's especially helpful when risk factors such as smoking present challenges for flap survival, he says.

Disclosures
Dr. Zilkha reports no relevant financial interests.
Dr. Montoneri is a trainer for RioBlush by Plum Systems Co.

For more information
www.clinique-montaigne.fr
www.RioBlush.com

Cellulite light
CO₂ rejuvenation provides advantages for addressing cellulite

John Jesitus
Senior Staff Correspondent

NATIONAL REPORT — Carbon dioxide injections represent a safe, effective option for addressing cellulite, particularly when combined with other treatments, sources say. For mild cellulite cases, they add, CO₂ injections sometimes can stand alone.

Also known as carboxytherapy, CO₂ therapy originated more than 50 years ago in France as a treatment for vasculopathies, says Yan Trokel, M.D., a New York-based cosmetic surgeon who has been using carboxytherapy for five years, including two years with the RioBlush system (Plum Systems Co, New York).

Over the years, physicians learned that CO₂ injections could provide cosmetic improvements as well. Italian and Brazilian researchers found that "People who get CO₂ treatment have increased vasculature and a little lysis of the most superficial adipocyte layer," Dr. Trokel tells Cosmetic Surgery Times. "Some also say that the treatment provides dermal improvement," with collagen bundles more tightly packed after treatment, he adds.

How it Works
Since CO₂ is a byproduct of the breathing process, Dr. Trokel says, "Receptors in the body actually pick up the [presence of] CO₂ and read it as an area of hypoxia or some sort of insult or trauma. The body responds by making new blood vessels and bringing in the nutrients needed to heal the area."

In his practice, Dr. Trokel says, "I really like the improvement in skin color and texture carboxytherapy provides around the eyes, because it improves the circulation and provides some dermal thickening." Because CO₂ is nonembolic, he adds, CO₂ therapy is very safe.

CO₂ and RF for Cellulite
In addition to treating the eye area, Dr. Trokel frequently uses carboxytherapy in combination treatments for cellulite. Carboxytherapy also can improve some very mild cases monotherapeutically, he adds.

"We know that CO₂ will improve the dermal collagen, so it can improve skin texture. The other benefit is that CO₂ therapy lyses some of the superficial fat, which creates that orange peel texture," he says.

The combination of CO₂ and radiofrequency (RF) energy in particular yields excellent results, Dr. Trokel says. He typically staggers eight weekly treatments of each, using VelaShape (Syneron; Yokneam, Israel) on Monday and carboxytherapy on Thursday, for example.

Dr. Trokel has tried applying topical anesthetic before carboxytherapy, "But the topical anesthetic doesn't do much because what patients are actually feeling is the gas moving as it's going in," he says. Patients usually find the treatment slightly uncomfortable, he says, particularly on the hands and back of the legs.

"The RioBlush system is fully programmable and heats the CO₂ gas to near body temperature, which reduces discomfort and increases efficacy," adds Glenn Fernandez, chief marketing and operations officer, RioBlush by Plum Systems Co.

"Gas temperature matters little in terms of pain for facial treatments since they involve small areas and smaller gas volumes. But I believe that heated gas improves treatment efficacy," adds Marian Zilkha, M.D., Ph.D., an ophthalmic plastic surgeon who practices in Brazil and coordinates aesthetic procedures at Manhattan's Integrative Center of Aesthetic Medicine (medical director: Alexander Kulick, M.D.). "And for body rejuvenation with higher gas volumes," she says, "heated gas is very important for pain management."

Regarding injection technique, Dr. Trokel says, "We use a 30-gauge needle to place the gas into the dermal layer, for a superficial effect, and deep into the fat layer, to stimulate lysis of the fat cells and new vasculature."

Each treatment area requires multiple injections. "I like to move the needle around circumferentially because this creates less distention, and patients feel less pressure," he says.

Treatments typically take 15 to 40 minutes total, says Dr. Trokel. Treating the face takes 20 to 30 minutes, while other areas such as the back of the legs or the abdomen require 15 to 20 minutes each, he explains.

After treatment, the treated area will raise, turn slightly red and undergo an inflammatory response. "The only side effect is that patients can bruise if one hits a vessel with the needle," he says. However, this only happens in around two percent of patients, he says.

"Once the procedure is done," says Dr. Trokel, "there's no pain," just possibly a crackling sensation under the skin that lasts until the gas is excreted. "I tell patients not to rub the area or immerse it in water for about four hours," he adds. External pressure can force the gas out prematurely, he explains. Similarly, Dr. Trokel advises patients not to bump the treated area due to temporarily increased skin and vessel fragility. However, he says that most patients can return to work immediately after treatment.

Results last about a year, after which patients usually return for touchup treatments. "I've seen some that have needed one or two touchup treatments, and some who needed the entire eight sessions again," Dr. Trokel says.

The Beauty Marathon
"Beauty isn't a race — it's a marathon," he says. Rather than waiting until their problems are bothersome again, Dr. Trokel says patients must appreciate that maintenance goes a long way.

Along with skin laxity, localized fat and vascular pooling (dark circles around the eyes), the RioBlush system also has been reported to provide effective treatment for reduction in the appearance of stretch marks, Mr. Fernandez adds. Moreover, physicians have reported success with the product in treating some kinds of hair loss, assisting wound healing (as in diabetic ulcers) and as a complement to liposuction, he says.

Although the RioBlush system is not currently FDA approved for marketing in the United States, Mr. Fernandez says, "We are in the process of preparing our FDA application and expect approval in 2009. We plan to begin clinical studies for a couple indications with some leading plastic surgeons and dermatologists to submit with our application." CST

Disclosures
Drs. Trokel and Zilkha report no relevant financial interests.

For more information
www.imageispower.com