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By Michelle Gardner
Recentadvances in wound management involve growth factors of diabetic foot ulcers.Among them is Apligraf by Novartis, a bi-layered living skin product approved bythe 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 usedthe product on patients with tremendous results.
Garoufalis sees a lot of diabetic wounds, ulcers and venous leg ulcers, aswell as the complications that accompany them.
"We have been treating wounds for years and doing various studies withdifferent wound care products. We are pretty well versed in what is going on inwound care," Garoufalis says. "We use the Apligraf instead of using askin graft. If we were to do a skin graft on these patients with ulcers, wewould 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 howcomplicated that could be."
Apligraf is genetically engineered and grown in the lab, and can be treatedjust like skin. "We mesh it like we mesh a skin graft and apply it to thewound," explains Garoufalis. "It jump-starts the wound and allows itto fill in and heal because the Apligraf has all the growth factors that ourskin would normally have in it. It even allows the tissue to repigment. Maybenot 100%, but it re-pigments."
In the original study provided to the FDA, Apligraf achieved 56% woundclosure in 12 weeks. "Some of the patients' wounds have been around foryears 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
Inan ideal world, a wound would be completely clean and free from bacteria beforea skin graft is applied. "That is a fairy tale," says Garoufalis."The wound is never clean. It is full of bacteria all the time, especiallya diabetic wound."
To combat "the bugs," the Westside VA decided to use a product fromHealthpoint called Iodosorb. "It is an iodine-containing compound that actslike a topical antibiotic," says Garoufalis. "It can kill the bugs inthe wound (and) acts as a great absorbent dressing."
Garoufalis admits that, in the beginning, people were hesitant about usingthe product because it contains iodine. "We all know we are not supposed touse a product like betadine on a wound because it is cytotoxic. It is damagingto tissues," he says. "But (Iodosorb) contains just the right amountof 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 woundsite," says Garoufalis. "If patients only have 50% of their bloodflow, how much of that systemic antibiotic is getting to the wound? Maybe notenough to take care of the bugs. If we can treat wounds topically, we are muchbetter off, and that is what we are finding."
Two Wound Classification Systems
The Association of periOperative Registered Nurses (AORN) applies theSpaulding Classification System to determine the correct processing methods forpreparing instruments and supplies for patient use based on the item and theintended use.1 The three categories in the Spaulding ClassificationSystem are:
Critical: Items or medical devices that enter sterile tissue or thevascular system should be subjected to sterilization before each use. Includedin the critical category are procedures in which the mucosal barrier is broken.
Semicritical: Items that come in contact with mucous membranes ornon-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 ClassificationSystem applies descriptive characteristics to predict the degree of microbialcontamination at the time of surgery. The four classifications are:
Class I/Clean: An uninfected surgical wound in which no inflammationis encountered and the uninfected respiratory, alimentary, genital, or urinarytract is not entered. In addition, clean wounds are primarily closed and, ifnecessary, drained with closed drainage. Surgical incisional wounds that occurafter nonpenetrating (i.e., blunt) trauma should be included in thiscategory if they meet the criteria.
Class II/Clean-contaminated: A surgical wound in which therespiratory, alimentary, genital, or urinary tracts are entered under controlledconditions and without unusual contamination. Specifically, surgical proceduresinvolving the biliary tract, appendix, vagina, and oropharynx are included inthis category, provided no evidence of infection or major break in technique isencountered.
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, andincisions in which acute, nonpurulent inflammation is encountered are includedin this category.
Class IV/Dirty-infected: This includes old traumatic wounds withretained devitalized tissue and those that involve existing clinical infectionor perforated viscera. This definition suggests that the organisms causingpostoperative infection were present in the surgical field before the surgery.
All four categories of wound classification should receive the same sterileand aseptic techniques to prevent exposure to microorganisms from anotherpatient or from personnel.
The Basics of Wound Care
For Roxanne Leisky, MSN/MBA, FNP-BC, CWS, clinical director for the CentralIllinois District of Patient Support Solutions Inc., most of her clients arenursing home residents and homebound patients. Of the wounds she sees, about 50%are pressure-related wounds caused by a bony prominence coming into contact witha 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," saysLeisky. "The first and most basic rule: if the wound is too wet, dry it. Ifit is too dry, moisten it. In order for a wound to heal, it must be kept in amoist environment. The cells needed for healing cannot 'migrate' to where theyneed to go if the wound bed is dry."
Leisky's second rule is, don't use something in the wound bed that iscytotoxic. "Common, older treatments are in this category, includingbetadine, acetic acid, hydrogen peroxide, and normal saline wet-to-drydressings," she says. "There are limited circumstances in which theseproducts are useful, but generally I don't use them."
Third, if a wound is necrotic, it needs to be debrided to clean out the deadtissue and get to the good tissue so healing can begin. Examples of debridementare sharp debridement (using a scalpel to cut away the tissue), enzymaticdebriders (medication placed in the wound bed to "eat" away the deadtissue), and pressurized saline to loosen the tissue.
"All wounds are essentially contaminated with bacteria, and often bynormal skin flora such as Enterococcus, Staphylococcus (seesidebar on page 42), Bacillus, or occasionally gram-negativeorganisms," says Leisky. "Distinguishing between contamination andinfection in wounds is often difficult. The clinically accepted indication ofwound infection is 105."
Once the necrosis is removed and the bed is clean, infection may be suspectedif healing or improvement does not occur within two weeks. "Typical localsigns of infection are redness, warmth, edema, pain, purulent discharge, andoften a foul odor," advises Leisky. "I try to treat these woundstopically to decrease the bacterial load."
Among specialists, there is ongoing debate as to whether pressure ulcers arepreventable, or if some will develop in high-risk patients, even when the bestcare is provided. And when it comes to tracking the development of wounds,especially in nursing-home patients, databases are incomplete. "There aremore than 300 studies with variation ranges," states Gail L. Lamoureux, RN,care coordinator for MedWise Primary Care in Largo, Fla. "Major terms areused inconsistently and there is uncertainty on how to conduct incidence andprevalence studies."
There are, however, ways to reduce the occurrence or severity of thesewounds. "Conduct a risk assessment, reassess as patient status changes,maximize mobility status, develop an individualized program of skin care, assureadequate 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 vascularcompetency, glycemic control in diabetes mellitus, and adequate nutritionalintake to maintain positive nitrogen balance. "Smoking, alcohol abuse,sleep deprivation, excess stress, and improper dressing also can hinder thespeed of recovery," says Lamoureux.
Help is on the Way
"It seems that every family practice or general internist has at leastone patient with a non-healing ulcer," says Maureen Knepp, PA-C, CWS, atDartmouth-Hitchcock Medical Center in Nashua, NH. "One percent of patients65 and older have venous hypertension. The evaluation of an ulcer starts with ahistory and looking for the three most common reasons people would have an ulcerin an extremity--diabetes, and arterial and venous insufficiency."
Venous ulcers are most commonly seen on the lower extremities and are usuallyassociated with varicose veins, previous deep-vein thrombosis orhypercoaguability disorders. Venous ulcers are irregularly shaped, and usuallyfound on the medial ankle. They can cause discoloration of the leg, andthickening 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 noone dressing that works on all types of wounds. It is up to the practitioner tomatch the dressing with the needs of the wound." She provides a short listof dressings used in wound care:
Compressionwraps like Unna's boots, Dynaflex, and Profore are bandages or a series ofbandages that reach from the toes to the knee to create a static or dynamicsqueeze to relieve edema in the leg and promote healing.
"These types of bandages are not applied until an ankle brachial indexis taken," explains Knepp. "This simple test for circulation is donewith a blood pressure cuff and a Doppler, and the systolic blood pressure istaken in all four extremities. The highest arm number is then divided into theankle pressure. This calculation is normally 1. If it is 0.8 to 0.9, the ulceris probably a venous ulcer. If it is 0.5 to 0.8, it is a part venous/partarterial ulcer. If it is below 0.5, it is arterial and concerns of limb loss areraised."
Trends in Wound Care
From the Unna's boot to bioengineered skin grafts, the area of wound care hasexploded during the last 20 years.
"I think the biggest change is that it is being covered more," saysRenee Cordrey, MSPT, MPH, CWS, manager of wound care services for Skilled HealthSystems in Los Angeles, Calif. "In the past, the focus was primarily thatwounds 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 schoolsare including an entire course (on wound care), with a specialized full-timefaculty member."
With graduate degrees in physical therapy and public health, Cordrey herselfincludes a variety of wound care topics in her teaching curriculum. "Icover anatomy and physiology, wound types and etiologies, the phases of healing,dressings, debridement, dressings, modalities, infection control, woundassessment and diagnostics, pressure reduction, orthotics, andpositioning," she says. "Points to address from various professionals(can include) nutrition, gait training and exercise, diabetes control, andsurgery."
As the physiology of wound care brings educational opportunities tospecialists, Cordrey sees a challenge in taking new knowledge about themolecular, cellular, and chemical workings and using it to improve the qualityof the wound care provided. "The resulting new technologies and approachesare exciting," she says.
Ina statement from The American Academy of Wound Management (AAWM),2wound care specialization is an important trend now recognized as a boardcertified specialty.
Dedicated wound care programs are increasingly caring for Americans withchronic wounds and could offer the potential to produce enhanced outcomes atreduced costs for payors and consumers of healthcare services. Evidence of thistrend can be found in a variety of recent reports and studies. A report by Frostand Sullivan indicates the US wound management products market is now $1.74billion and should grow to $2.57 billion this year. The cost of treating thechronic wound is estimated at $5 billion to $7 billion, and these wounds areincreasing at a rate of 10% per year, according to the report.
The development of the AAWM, a national, non-profit certifying board, isanother indication that wound care is coming into its own as an industry. BoardCertification is now available for physicians, nurses, therapists, researchers,and other healthcare professionals involved in wound care. More than 1,000 woundcare professionals have requested applications for board certification throughAAWM.