Uneventful Process or Complex Medical Problem Requiring
Specialized Treatment and Care?
By Michelle Gardner
Recent advances in wound management involve growth factors of diabetic foot ulcers. Among them is Apligraf by Novartis, a bi-layered living skin product approved by the US Federal Drug Administration (FDA) for venous ulcers and diabetic ulcers. Apligraf has a dermis and an epidermis like human skin. Matthew G. Garoufalis, DPM., chief of the podiatry section at VA Chicago HealthCare System, has used the product on patients with tremendous results.
Garoufalis sees a lot of diabetic wounds, ulcers and venous leg ulcers, as well as the complications that accompany them.
"We have been treating wounds for years and doing various studies with different wound care products. We are pretty well versed in what is going on in wound care," Garoufalis says. "We use the Apligraf instead of using a skin graft. If we were to do a skin graft on these patients with ulcers, we would have to take skin from somewhere else on their bodies and, in essence, create another wound to heal the one on their lower leg. You can imagine how complicated that could be."
Apligraf is genetically engineered and grown in the lab, and can be treated just like skin. "We mesh it like we mesh a skin graft and apply it to the wound," explains Garoufalis. "It jump-starts the wound and allows it to fill in and heal because the Apligraf has all the growth factors that our skin would normally have in it. It even allows the tissue to repigment. Maybe not 100%, but it re-pigments."
In the original study provided to the FDA, Apligraf achieved 56% wound closure in 12 weeks. "Some of the patients' wounds have been around for years and we haven't been able to close them," shares Garoufalis. "Here comes (Apligraf) and we are seeing dramatic results."
To Apply or Not to Apply
In an ideal world, a wound would be completely clean and free from bacteria before a skin graft is applied. "That is a fairy tale," says Garoufalis. "The wound is never clean. It is full of bacteria all the time, especially a diabetic wound."
To combat "the bugs," the Westside VA decided to use a product from Healthpoint called Iodosorb. "It is an iodine-containing compound that acts like a topical antibiotic," says Garoufalis. "It can kill the bugs in the wound (and) acts as a great absorbent dressing."
Garoufalis admits that, in the beginning, people were hesitant about using the product because it contains iodine. "We all know we are not supposed to use a product like betadine on a wound because it is cytotoxic. It is damaging to tissues," he says. "But (Iodosorb) contains just the right amount of iodine to kill the bugs but is not damaging to tissue."
In a 20-patient study, Garoufalis used Apligraf and Iodosorb over the graft, which resulted in 100% closure in eight weeks.
"IV or oral antibiotics are dependent on blood flow to get to the wound site," says Garoufalis. "If patients only have 50% of their blood flow, how much of that systemic antibiotic is getting to the wound? Maybe not enough to take care of the bugs. If we can treat wounds topically, we are much better off, and that is what we are finding."
Two Wound Classification Systems
The Association of periOperative Registered Nurses (AORN) applies the Spaulding Classification System to determine the correct processing methods for preparing instruments and supplies for patient use based on the item and the intended use.1 The three categories in the Spaulding Classification System are:
Critical: Items or medical devices that enter sterile tissue or the vascular system should be subjected to sterilization before each use. Included in the critical category are procedures in which the mucosal barrier is broken.
Semicritical: Items that come in contact with mucous membranes or non-intact skin and require a minimum of high-level disinfection.
Noncritical: Items that come in contact with intact skin only.
The Centers for Disease Control and Prevention (CDC) Wound Classification System applies descriptive characteristics to predict the degree of microbial contamination at the time of surgery. The four classifications are:
Class I/Clean: An uninfected surgical wound in which no inflammation is encountered and the uninfected respiratory, alimentary, genital, or urinary tract is not entered. In addition, clean wounds are primarily closed and, if necessary, drained with closed drainage. Surgical incisional wounds that occur after nonpenetrating (i.e., blunt) trauma should be included in this category if they meet the criteria.
Class II/Clean-contaminated: A surgical wound in which the respiratory, alimentary, genital, or urinary tracts are entered under controlled conditions and without unusual contamination. Specifically, surgical procedures involving the biliary tract, appendix, vagina, and oropharynx are included in this category, provided no evidence of infection or major break in technique is encountered.
Class III/Contaminated: This includes open, fresh, accidental wounds. In addition, surgical procedures with major breaks in sterile technique (e.g., open cardiac massage), gross spillage from the gastrointestinal tract, and incisions in which acute, nonpurulent inflammation is encountered are included in this category.
Class IV/Dirty-infected: This includes old traumatic wounds with retained devitalized tissue and those that involve existing clinical infection or perforated viscera. This definition suggests that the organisms causing postoperative infection were present in the surgical field before the surgery.
All four categories of wound classification should receive the same sterile and aseptic techniques to prevent exposure to microorganisms from another patient or from personnel.
The Basics of Wound Care
For Roxanne Leisky, MSN/MBA, FNP-BC, CWS, clinical director for the Central Illinois District of Patient Support Solutions Inc., most of her clients are nursing home residents and homebound patients. Of the wounds she sees, about 50% are pressure-related wounds caused by a bony prominence coming into contact with a surface area for too long.
"Each wound is treated on a case-by-case basis, but there are a few 'golden rules' to wound care that dictate what procedure is used," says Leisky. "The first and most basic rule: if the wound is too wet, dry it. If it is too dry, moisten it. In order for a wound to heal, it must be kept in a moist environment. The cells needed for healing cannot 'migrate' to where they need to go if the wound bed is dry."
Leisky's second rule is, don't use something in the wound bed that is cytotoxic. "Common, older treatments are in this category, including betadine, acetic acid, hydrogen peroxide, and normal saline wet-to-dry dressings," she says. "There are limited circumstances in which these products are useful, but generally I don't use them."
Third, if a wound is necrotic, it needs to be debrided to clean out the dead tissue and get to the good tissue so healing can begin. Examples of debridement are sharp debridement (using a scalpel to cut away the tissue), enzymatic debriders (medication placed in the wound bed to "eat" away the dead tissue), and pressurized saline to loosen the tissue.
"All wounds are essentially contaminated with bacteria, and often by normal skin flora such as Enterococcus, Staphylococcus (see sidebar on page 42), Bacillus, or occasionally gram-negative organisms," says Leisky. "Distinguishing between contamination and infection in wounds is often difficult. The clinically accepted indication of wound infection is 105."
Once the necrosis is removed and the bed is clean, infection may be suspected if healing or improvement does not occur within two weeks. "Typical local signs of infection are redness, warmth, edema, pain, purulent discharge, and often a foul odor," advises Leisky. "I try to treat these wounds topically to decrease the bacterial load."
Among specialists, there is ongoing debate as to whether pressure ulcers are preventable, or if some will develop in high-risk patients, even when the best care is provided. And when it comes to tracking the development of wounds, especially in nursing-home patients, databases are incomplete. "There are more than 300 studies with variation ranges," states Gail L. Lamoureux, RN, care coordinator for MedWise Primary Care in Largo, Fla. "Major terms are used inconsistently and there is uncertainty on how to conduct incidence and prevalence studies."
There are, however, ways to reduce the occurrence or severity of these wounds. "Conduct a risk assessment, reassess as patient status changes, maximize mobility status, develop an individualized program of skin care, assure adequate nutrition, keep skin clean and dry, and protect against pressure, friction, and shear," advises Lamoureux.
Even wounds that have the ability to heal depend on variables like vascular competency, glycemic control in diabetes mellitus, and adequate nutritional intake to maintain positive nitrogen balance. "Smoking, alcohol abuse, sleep deprivation, excess stress, and improper dressing also can hinder the speed of recovery," says Lamoureux.
Help is on the Way
"It seems that every family practice or general internist has at least one patient with a non-healing ulcer," says Maureen Knepp, PA-C, CWS, at Dartmouth-Hitchcock Medical Center in Nashua, NH. "One percent of patients 65 and older have venous hypertension. The evaluation of an ulcer starts with a history and looking for the three most common reasons people would have an ulcer in an extremity--diabetes, and arterial and venous insufficiency."
Venous ulcers are most commonly seen on the lower extremities and are usually associated with varicose veins, previous deep-vein thrombosis or hypercoaguability disorders. Venous ulcers are irregularly shaped, and usually found on the medial ankle. They can cause discoloration of the leg, and thickening and scaling of the skin.
According to Knepp, most ulcers take three months on average to heal. "With the proper dressing and treatment, this time can be shortened, improving the quality of life for the patient," she says. "There is no one dressing that works on all types of wounds. It is up to the practitioner to match the dressing with the needs of the wound." She provides a short list of dressings used in wound care:
- Foam is meant to absorb heavy drainage, and help promote a moist environment and autolytic debridement.
- Calcium alginates come from brown seaweed and absorb 20 times their weight. They keep a wound moist, and helps autolytic debriding of the wound.
- Hydrogels hydrate a dry wound with minimal absorption, soothing and promoting wound healing.
- Hydrocolloids are impermeable to bacteria and aid in autolytic debridement, self-adherence, and moist healing. They may be left in place for 3 to 5 days, but cannot be used if infection is present.
Compression wraps like Unna's boots, Dynaflex, and Profore are bandages or a series of bandages that reach from the toes to the knee to create a static or dynamic squeeze to relieve edema in the leg and promote healing.
"These types of bandages are not applied until an ankle brachial index is taken," explains Knepp. "This simple test for circulation is done with a blood pressure cuff and a Doppler, and the systolic blood pressure is taken in all four extremities. The highest arm number is then divided into the ankle pressure. This calculation is normally 1. If it is 0.8 to 0.9, the ulcer is probably a venous ulcer. If it is 0.5 to 0.8, it is a part venous/part arterial ulcer. If it is below 0.5, it is arterial and concerns of limb loss are raised."
Trends in Wound Care
From the Unna's boot to bioengineered skin grafts, the area of wound care has exploded during the last 20 years.
"I think the biggest change is that it is being covered more," says Renee Cordrey, MSPT, MPH, CWS, manager of wound care services for Skilled Health Systems in Los Angeles, Calif. "In the past, the focus was primarily that wounds needed wet-to-dry dressings, and throw them in a whirlpool if it's messy. Now, many disciplines are including more about the physiology of healing, advanced dressings, and treatments available to help wound care. Some schools are including an entire course (on wound care), with a specialized full-time faculty member."
With graduate degrees in physical therapy and public health, Cordrey herself includes a variety of wound care topics in her teaching curriculum. "I cover anatomy and physiology, wound types and etiologies, the phases of healing, dressings, debridement, dressings, modalities, infection control, wound assessment and diagnostics, pressure reduction, orthotics, and positioning," she says. "Points to address from various professionals (can include) nutrition, gait training and exercise, diabetes control, and surgery."
As the physiology of wound care brings educational opportunities to specialists, Cordrey sees a challenge in taking new knowledge about the molecular, cellular, and chemical workings and using it to improve the quality of the wound care provided. "The resulting new technologies and approaches are exciting," she says.
In a statement from The American Academy of Wound Management (AAWM),2 wound care specialization is an important trend now recognized as a board certified specialty.
Dedicated wound care programs are increasingly caring for Americans with chronic wounds and could offer the potential to produce enhanced outcomes at reduced costs for payors and consumers of healthcare services. Evidence of this trend can be found in a variety of recent reports and studies. A report by Frost and Sullivan indicates the US wound management products market is now $1.74 billion and should grow to $2.57 billion this year. The cost of treating the chronic wound is estimated at $5 billion to $7 billion, and these wounds are increasing at a rate of 10% per year, according to the report.
The development of the AAWM, a national, non-profit certifying board, is another indication that wound care is coming into its own as an industry. Board Certification is now available for physicians, nurses, therapists, researchers, and other healthcare professionals involved in wound care. More than 1,000 wound care professionals have requested applications for board certification through AAWM.