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Friday, February 24, 2012

Wound care products--a rapidly expanding market, and way too expensive

About 15 years ago a non-healing wound on a  person with diabetes or vascular disease was treated by surgeons and primary care physicians, sometimes by podiatrists, and would take months or years to heal and often lead to amputation. Wounds like this were depressing for both patients and physicians because they combined pain and hopelessness and resulted in death, disability and use of lots of resources.

Starting about 10 years ago, I started to see, from my primary care practice, fancier wound dressings and doctors and nurses who specialized in taking care of wounds and ulcers. This was a great relief to those of us on the front line, struggling and failing to heal these things. The success rate for healing seemed to improve, but ever so slowly.

The problems with healing a wound involve the fact that wounds happen for a reason, unhealthy tissue or lack of sensation leading to injury or fluid buildup from internal problems or pressure due to immobility. Many of these issues will continue to encourage wounds to stay open while care providers are doing what they can to make the wound close. Also, open skin leads to bacterial growth and infection, and once bacteria establish in a wound, it is difficult for it to close. The treatments that are intended to reduce bacteria, like antibiotic and antiseptic chemicals often are toxic to growing skin cells as well as infecting bacteria. The old fashioned "wet to dry" dressing had just this problem. Gauze was placed on a wound wet, allowed to dry, then pulled off taking infected goo and healthy skin with it. It was usually counter productive and incredibly painful.

Wounds can be dry, with a stable scab that doesn't want to heal, or wet, sometimes oozing spoonfuls of lymph and such in a day. They can be small and deep or large and superficial. They can involve structures underneath, such as bone and muscle. All of these different kinds required different approaches.

Wound care products attempt to address all of these issues with creativity and technology and often include pieces of folk wisdom and stuff that worked in the past. We have greasy zinc oxide paste with herbal additions to prevent breakdown of chronically wet skin on bottoms, much like the old fashioned desitin which was probably used on the bottoms of my generation of babies. We have absorbent products made of various types of foams and fibers, some containing antibiotics, but more often silver, since it is antibacterial without being irritating or inhibiting skin growth. We have lab grown skin graft material that can be used to cover a clean wound that needs more active healing. There are dressings that are made of sticky wax that can stay on for days to protect an ulcer in a place that gets lots of friction. In the last few years particularly gnarly wounds have begun to be treated with wound vacuums (wound vacs) that place gauze or foam on the wound and then create a small amount of suction meant to pull tiny blood vessels and healing fluids to the surface to improve healing. These also conveniently remove pus and liquid from wounds that exude so much that they can't be kept clean. Hyperbaric chambers expose people to high levels of oxygen which can heal stubborn wounds that don't respond to the usual treatments. There are new topical gels and ointments that use such things as honey and silver as well as iodine and anitibiotics, and there are products that use the body's growth factors to improve cell growth.

Lots of hope, but at a really high cost! The foam or fiber dressings cost between $150 and $250 for a box of 10 four inch squares. The gels cost upward of $80 for 1.5 ounces. A day on a wound vac in a nursing home costs nearly $100, paid by medicare until the benefit is exhausted. A day in a hyperbaric chamber can cost from $200-$1000 depending on whether it is located in a hospital or a private clinic (more expensive at hospitals.) Wounds are healing  up faster than they used to do and are more comfortable and less smelly for patients. The basics required to heal a wound remain the same: good nutrition, not smoking, avoiding infection or reinjury and improving blood flow. Fancy dressings are helpful, but their relative contribution compared to the basics is small.

Ideally what we need is a magic potion that heals wounds cheaply and relieves pain. It would be nice if it also was readily available and didn't require refrigeration. If such a thing existed, though, we would already be using it. Or would we?

The wound care industry is growing faster than health services in general, and products that can be made and patented and sold for lots of money, especially to patients with good enough insurance to pay for them, drive this development. Surely there are great new products out there, and I congratulate the innovators who come up with these new ideas. But this mechanism and these incentives do not favor the development of cheaper or simpler approaches. There are public funding sources in medical research, but industry really drives the development of products.

Enter heparin. Heparin is one of the oldest drugs still used, first isolated from dog liver in 1916 at Johns Hopkins and used in humans to inhibit blood clotting beginning in 1936. It is a chemical released at the location of injury, and probably functions more to stop infection and increase healing than to stop blood clotting in its natural state. Nobody holds a patent on it anymore. It is known to increase the growth of blood vessels in animal models, and it is used extensively in the treatment of burns in many countries. I can find only a few studies on its use in treating wounds, though there is abundant information on its effectiveness from the places that routinely use it to treat burns. Evidence suggests that in the treatment of burns it dramatically reduces pain and speeds healing. It is used intravenously for very large burns, like those related to explosions, and is applied topically for smaller burns. But wounds are another question.

Michael Saliba MD studied burns in an animal model decades ago at UC San Diego and has since been involved in trying to get out the word of its effectiveness. He has lots of research to support its use, but most of it is done outside of the US and the very fact that it works so well makes blinded studies impractical. Some research is ongoing. Since it relieves pain so effectively, those treating patients with it know who is getting it and who is not. Healing is also much faster, which is hard not to notice. It is used most commonly in resource poor countries (Nepal, India, Mexico, Bulgaria, El Salvador to name a few) due to its very low cost, and withholding an effective treatment in life or death situations is difficult to condone. So frustrating. Something that really works, and because of its familiarity it essentially flies under our radar.

When I asked Dr. Saliba about non-burn uses for heparin, given its mechanism of action, he told me that it did work for many chronic ulcers. I was in the process of leaving my primary care practice at the time, but had the occasion to use it once before I left. The patient was a big smoker who had just had a heart attack and had then fallen down, jabbing a sharp piece of pipe into the front of her leg. After a few weeks of dressing it, it had still not begun to heal and she was beginning to have a really nasty rash in response to the sticky dressings that was beginning to turn the whole leg into an oozing piece of meat. It was imperative that I use some sort of treatment that didn't require a fancy dressing. I went across the street to the hospital and bought some vials of heparin and applied them to the wound. I then wrapped it with gauze. The next day she was better, and so on until she was completely healed in about 2 weeks. Pretty cool, I thought.

Since that time I have been working as a hospital doctor and haven't had the opportunity to treat wounds myself. Most hospitals have specific wound care services and I felt uncomfortable pushing my new and clearly  unconventional ideas about topical heparin. But 3 days ago I got back home after a week away working and found that my son, who had just started a martial arts conditioning class, had torn the skin off of his knuckles which were painful and oozing. He figured he wouldn't be able to go back the next day and punch the heavy bag. I found one of my little leftover vials of heparin, dabbed it on, let it soak awhile, put on bandaids and he was almost totally healed the next day. Wow. A diabetic friend with an ulcer on his ankle  that was really cramping his style (coincidentally also this week) asked for advice and I suggested the heparin and a bandaid technique and (I'm told) after applying it at night he could barely find the spot in the morning. Wow again.

I am stymied. Having cognitive dissonance. Confused. What is with this whole heparin thing and why don't we use it? I went to wikipedia and the author of the heparin article mentioned many possible uses for heparin, but not wound healing or burns. I found one article that really pertained to the question on a google search  ( which suggests in its abstract that heparin really does work for wound healing, but it was published in 1996 in the Journal of Ostomy and Continence Nursing. Something with that level of impact on practice should have been on the front page of the New England Journal, and followed up instantly by other journals with confirming or explanatory articles.

Since the main wound care nurse at my hospital is a good friend, I think it's likely that we will get a chance to try heparin more often and see if it lives up to what I have seen so far. The treatment of large burns is not within my practice, but maybe I'll have a chance in the next year or two to visit places where it is used. Certainly the coming focus on bundling payment for conditions (which will include burns) will introduce a powerful incentive to look at therapies that are effective and inexpensive. Until that time, I hope if I get a big burn it will happen in Mexico!


Anonymous said...

Regarding the ankle wound (which was mostly an area of rawness and sensitivity that had been extremely slow to heal for 3 weeks), not only was it hard to find the next day, but the pain relief was almost instant, and by the next day there was no discomfort at all.

Anonymous said...

I want to confirm the accuracy of Anonymous' account (I'm the wound person) and share this:

I have diabetes and circulatory problems in my lower right leg and I've had 3 occasions where I've had an injury there. The first time was quite serious. I was put on 3 different antibiotics and went on disability from my job for six weeks (but because of some technicality which I still don't understand, I received no benefits. I had no income for six weeks, another "cost" of health care in this country.

In the current case, after self treating for over a week with Neosporin and bandages there was only slight improvement. The wound still looked scary so I went to the doctor and was put on antibiotics. By the time I received the Heperin the wound was about 90% healed, still showing some lesion and still very sensitive to the touch, not just topically but also down deep. I watched the Heperin soak into my skin and disappear after about 5 minutes. I then put a dry piece of gauze over the wound and re-wrapped it and noticed the pain wasn't there. About 12 hours later when I checked the wound I could not even see it and here's the thing that I find most astounding. Even without a wound, the tissues on my leg are very sensitive to any pressure or touch but the next day pushing on the area of the wound produced no pain in the deep tissue area.

BTW and FYI, I have no health insurance. As of November I receive $876/month in social security (I've been looking for a job since Feb '11 when I was layed off without benefits because I was and independent contractor) and will have to re-apply for "County Medi-Cal" for which I'm told I will have a share of cost on account of my vast increase in wealth. This insurance will last only 6 months and took 2 months to be approved last time I applied. My coverage expired Nov. 30th and I'm waiting. Fortunately they do back-date the coverage which will eventually pay my bill.

Hurray for Dr. Janice for asking the good hard questions and who truly cares and for a dear friend Anonymous who cares too.