Here’s new hope for eradicating the inevitable byproducts of surgery

Skin is all around us—it surrounds our bodies and is a major concern in plastic surgery practices. In the past few years, my practice has been inundated with the “latest and greatest” solutions for daily skin care, including topical solutions for specific indications. I am sure this is true of your practice as well. We cannot turn on the television or read a journal without being bombarded with advertisements touting some new cream, lotion, or potion.

It is obvious that a solution is needed that addresses one of the least-desired attributes of our patients: visible scars. In the May/June 2005 issue of the Aesthetic Surgery Journal, McGrath and Chang reported that when plastic surgeons were asked whether they recommend products to patients to help reduce the appearance of scars, 89% of the respondents replied that they did.1 However, the authors also stated that, “Only 40% of the plastic surgeons noted a positive effect of topical treatment more than half the time, and 6% actually doubted [its] efficacy.” Most of the surgeons who were skeptical were in the 11% who did not recommend topical-treatment products.

There is also this report in the July 2004 edition of the Pharmacist’s Letter on over-the-counter (OTC) scar products:

“Vitamin E capsules are often opened and rubbed on the scar. Tell people it doesn’t work . . . and can cause contact dermatitis. Topical steroids don’t help. They’re probably not absorbed well. Onion extract . . . is heavily promoted for scars . . . but so far there’s not enough proof that it’s effective.”2


The Inevitable Scar

According to the American Society of Anesthesiologists, more than 25 million surgical procedures are performed each year, each potentially resulting in a scar.3 Countless other injuries also lead to scars. Yet, the options for effective treatments are limited.

It is clear to me, however, that there is a significant need to effectively modulate scarring. Each and every day in surgery, I create a scar on a patient, and, from the typical Baby Boomer to the teenager, they all request a topical solution to help eliminate the scar.

In contrast to the many unrealistic claims we all have heard, I cannot perform “scarless surgery.” Therefore, I recommend postoperative scar therapy for every patient—as I believe we all should. I fully understand that many scars will flatten and fade over a period of 1 year, but why take the risk for those that do not? If we can help reduce the appearance of scars effectively and possibly within 1 year, would it not be worthwhile to begin using a product routinely—perhaps even to help prevent hypertrophic scarring or keloid scars?


Proactive Patients

Patients today like being proactive about everything in their lives. With information from the Internet available at their fingertips, they are far more educated consumers than they used to be. As New Age patients have become more educated, they have become label readers as well!

As a result, I have observed—and you may have as well—that a startling number of patients are now asking what they can put on their scars. These well-informed and motivated patients seem to prefer hearing about something besides just vitamin E, cocoa butter, or shea butter.

In my opinion, scars should be dealt with in the postoperative routine, and not just left to chance. The appearance of unsightly scars may not seem important to everyone, but to the person who has one, it is a very significant problem.

In the same way that prophylactic antibiotics are prescribed for many surgeries, perhaps “prophylactic scar therapy” should be prescribed for every surgical incision or traumatic injury that can potentially leave a scar. This would require us to change our behavior and—perhaps more importantly—our attitudes about scar modulation. With only 89% of plastic surgeons recommending scar-reduction therapy (I believe it should be 100%), I cannot imagine what the tens of thousands of general, cardiac, and obstetric and gynecological surgeons are recommending—if anything.


Little Choice

The real problem regarding scar therapies is twofold. First, the gold standard—silicone-gel sheeting—is difficult to use and uncomfortable; thus, compliance is low. Second, regardless of efficacy, if we cannot get patients to comply, our efforts are worthless.

In response to the need for an alternative, a plethora of new topical scar therapies have entered the market. In fact, at the American Society of Plastic Surgeons’ annual meeting last fall in Chicago, no fewer than five booths were dedicated to “new and exciting” scar therapies. The problem with most of the topical products out there, however, is that they have no proven efficacy.

Some are based on onion extract, which has never really been shown to work, and many others are silicone-based creams. I am not even sure what one of the newest, and currently most heavily advertised, products is based on; its ingredient list is overwhelming.

The main problem that I have with the silicone products is that their producers cite silicone-gel sheeting research as proof to substantiate their claims. Unfortunately, as you know, the two are not the same, especially when you consider that one of the theories behind the efficacy of silicone-gel sheeting is its moisture barrier or occlusive action. Thus, it is imperative that clinical studies be done on silicone liquid and gel formulations before they are widely used.

The ideal scar-therapy alternative to silicone-gel sheeting must first of all have proven efficacy. It should also be moisturizing, absorbent, hypoallergenic, anti-inflammatory, and convenient so as to increase the incidence of compliance.


A New Approach

My recent experience with a novel approach to scar management leads me to believe that we need to think outside the box. The product that I am currently testing—and have been for almost 2 years—exhibits all of the desired properties. Unlike the current offerings for topical scar modification, its formulation is completely unique.

It consists of a specially processed oil that contains a combination of essential omega-3 and omega-6 fatty acids. This oil intrigued me because several independent studies showed that it is highly moisturizing, has transdermal properties, may have anti-inflammatory properties, and is well tolerated in burn patients.

As you know, inflammation plays a critical role in scar formation. An incision through the skin produces inflammation, and with the inflammation comes scarring.

One theory requires control of inflammation to control the scar. Yet, no current topical product offering (except silicone-gel sheeting) can address this concern.4 In fact, onion extract, silicone creams, and topical steroids have not been shown to decrease inflammation associated with scarring.5 Also, none have been shown to adequately penetrate the epidermis and directly interfere with the inflammation process.

My experience with conducting previous scar-product evaluations, along with the properties of this oil, led me to investigate its use as a scar therapy. I designed a pilot study to test the product on breast-reduction patients. They are the ideal candidates for a study because they have identical mirror-image scars—that is, paired control and test scars.

The results of the pilot study were astounding. Not only was there a visible result (the control was a leading OTC topical-scar therapy based on onion extract), but 100% of the patients preferred the oil over the other product. Scars faded and softened more quickly. In fact, every patient asked if she could stop the OTC product and use the new oil exclusively. Figure 1 shows the first patient enrolled in the pilot study.


The Clincher

The clincher for me was treating a few desperate patients, including a woman with a devastating dog bite on her face. This patient was bitten by her own dog. Her scars were very obvious—red, raised, and inflamed—so she was reluctant to go out in public. She came to me for a scar consultation, and I told her that I was afraid that I could not help her immediately and that she would most likely need surgical scar revision. She was not happy with this conclusion.

As an afterthought, and be­cause of her desperation, I grabbed a bottle of the study oil and asked her to try it. The outstanding results (Figure 2) have made her quite a proponent of this product. In fact, like the breast-reduction patient, she encouraged me to market the oil and hopes that it will be available to patients everywhere.


Clinical Test

However, because the product was not clinically tested, and was therefore in the same category as every other product that lacked adequate scientific proof, I decided that it needed to be backed by a university-based, institutional review board–approved, randomized double-blind clinical trial. I submitted a study protocol, and it was approved on August 22, 2005.

I am not at liberty to report specifically on the study, but I can state that it is proceeding as scheduled and I am continuing to enroll patients. I have faith and hope for this new and exciting alternative to existing topical scar options.

The feedback I have received from my patients, as well as the obvious results I have observed, dictate my resolve. However, I echo the conclusion in McGrath and Chang’s article: “Physicians and surgeons should be watchful to avoid the use of unproven products.”1 I anticipate publishing the results of our clinical trial in mid-2007.

Despite the lack of published clinical evidence on the efficacy of topical scar treatments, it is my belief that prophylactic scar therapy will become commonplace not only in the field of plastic surgery, but in all surgical disciplines. Furthermore, we are initiating a pilot study to improve the appearance of chronic scars using a new particle-free, bristle-treatment-tip skin-resurfacing device that uses hydro-assisted dermabrasion, immediately followed by an application of our fatty-acid oil previously discussed.

With the advent of the Internet and the explosive increase of emerging technologies, these are exciting times. I hope that one day, using technology for the skin, we will be able to solve the problem of scars. PSP

Jerome D. Chao, MD, is a board-certified plastic surgeon and an assistant professor of surgery at Albany Medical College, NY. He received his medical degree from the College of Physicians and Surgeons of Columbia University, New York City. He can be reached at jdc345@hotmail.com

Chris Doster is a marketing consultant with more than 15 years of experience in medical- and aesthetic-product sales. He and Chao are coauthors of the book Skin Is In—Secrets of a Plastic Surgeon, to be published in summer 2006 by MD Publications Inc. He can be reached at cldfree@aol.com


References

1. McGrath MH, Chang DS. Topical scar modification: Hype or help? Aesthetic Surg J. 2005;25:304–306.

2. Dermatology. Pharmacist’s Letter. 2004(July);Vol. 20. Available at: http://www.pharmacistsletter.com Paid membership required to access.

3. American Society of Anesthesiologists. Anesthesia and you. Available at: http://www.asahq.org/patienteducation/anesandyou.htm Accessed Feb-ruary 13, 2006.

4. Ahn S, Monafo WW, Mustoe TA. Topical silicone gel for the prevention and treatment of hypertrophic scars. Arch Surg. 1991;126:499–504.

5. Jenkins M, Alexander JW, MacMillan BG, Waymack JP, Kopcha RJ. Failure of topical steroids and vitamin E to reduce postoperative scar formation following reconstructive surgery. Burn Care Rehabil. 1986:7: 309–312.