Expanding Wound Care Protocols

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November 2001

By Carrie Sussman, PT

Carrie Sussman, PT

Expanding Wound Care Protocols
Information on new wound healing therapies comes out almost daily. Many of the therapies are advanced therapies to stimulate the healing of refractory wounds-meaning wounds that have not healed despite appropriate treatment.¹ Therapies of this type may include topical products as well as devices. They typically cost more than conventional wound therapies, which results in a controversy as to whether to initiate care with these more costly interventions when conventional therapy has failed and the wound is already in the refractory state, or to identify the patients with wounds that are likely to become refractory and begin initially. Consequently, the rehab manager must develop management strategies for identifying the most appropriate wound healing interventions and criteria for candidacy before introducing new therapies into the wound clinic protocol.

There is an abundance of published literature and product sales materials all claiming to have found the ideal wound care product. The rehab manager must scrutinize the materials carefully to discern the validity and reliability of the claims made. What do rehab managers need to know about new wound therapies to discern from this abundant material which products to add to the clinic armamentarium?

The Evaluation process
Evidence of efficacy and safety, cost-effectiveness, comparison to other therapies, ease/availability of use, liabilities, and candidacy for the therapy are guidelines for evaluating new wound therapies.

Evidence-based practice is practice based on proof. Proof comes from scientific research and is applied with clinical judgement. Reliable sources are available to help the rehab manager evaluate the evidence. Caution should be used before extrapolating information from animal studies to humans and generalizing one type of wound to another. Some reliable sources of information include the National Library of Medicine, clinical practice guidelines,^2,3 systematic clinical reviews, and evidence-based textbooks and peer-reviewed journals. Levels of evidence have created3, ⁴ a quality rating scale for evidence. Randomized controlled clinical trials are at the highest level and are the gold standard for research evidence for clinical studies, but controlled studies comparing treatments, clinical case studies, poster and oral presentations at national meetings, and product package inserts are all valid means of evaluating evidence.

Product package inserts are a practical way to quickly determine safety and efficacy of wound care products. Claims, indications, warnings, and contraindications that appear in package inserts are reviewed by the federal Food and Drug Administration (FDA) before it grants clearance to market the product. FDA has specific classifications of products with different evidence requirements for each classification. A caveat here is that many wound care products are approved as equivalent to products that have met the tests for safety and efficacy but may not have been clinically tested. The FDA does not require comparative efficacy studies before granting marketing clearance.⁵ Products that pass this test should be considered for inclusion in the facility's evidence-based protocol of care.

Cost-Effectiveness
Cost-effectiveness refers to the cost of achieving a desired outcome of treatment and is calculated by adding direct and indirect costs and measuring the outcome based on the goals of care.6 Some direct costs include dressing, debridement, physician, and nonphysician provider costs. Indirect costs include treatment for complications, loss of work, and disposal of soiled wound care products. For example, a new wound care dressing may be more costly but could be more cost-effective than standard saline-soaked gauze because it heals the wound faster or causes less pain and trauma to the wound. Unfortunately, studies reported in the literature usually measure only the cost of an intervention without evaluating the cost to reach a specific outcome, such as length of time for healing or effect on quality of life.

Comparison criteria could include length of time to achieve benchmarks of healing such as clean, necrosis-free, infection-free, granulating, and epithelializing. If the new treatment reduces the healing time a statistically significant amount compared to standard care, it would be a benefit. If the product reduces a patient's pain, physical and/or emotional, more effectively than standard treatment intervention, it may be warranted. If the product manages wound exudate so the wound has less odor or there is less pain, it would have a favorable recommendation. The new therapy may be more cost-effective than standard care. In some cases, new therapies may be less costly and at least as effective as other interventions and should replace older methods of treatment.⁶

Products that can be easily applied will get a thumbs up while those that are troublesome to apply will get a thumbs down. If the product cannot be accessed readily by or for the patient, then it would be ruled out.

Rehab managers must be familiar with the proper, safe administration of any treatment, and understand the expected outcomes and possible negative effects. They are liable for the consequences of misuse and inappropriate care.

No single therapy intervention will be a magic bullet to heal all refractory wounds. The rehab manager should develop criteria for choosing different wound interventions based on the patient history, wound etiology, wound severity, wound characteristics, and evidence of product safety and efficacy. Candidacy criteria should become part of the evidence-based wound therapy protocol.

Management of Infection and Tissue Regeneration
Bacterial contamination of wounds has been identified as retardant to wound healing. Bacteria in a wound compete for nutrients and oxygen and excrete waste products containing toxins that retard wound healing. The most common source of contamination is from necrotic tissue in the wound. Antiseptics cannot kill bacteria within tissue so other methods of managing infection are required.

Cadexomer iodine (CI). A combination of polysaccharide polymer, cadexomer, and iodine at low strength, CI has a high degree of absorption. It is applied directly to the wound as either a powder, paste, or dressing and left in place for up to 3 days. As the CI absorbs wound fluid, bacteria, and toxins, it slowly releases iodine over the 3-day period.⁷ Several studies have found CI beneficial for controlling infection and speeding wound healing, but the mechanism of action may not be its ability to disinfect through release of iodine, but rather its absorptive properties.8 CI meets the criteria of having good-quality supporting evidence, cost-effectiveness, ease of use, and availability, and is currently a recommended therapy to include in wound healing protocols.

Silver release dressings. Another classification of antimicrobial products receiving lots of notice is the silver release dressings. Silver has been used as an antimicrobial for more than 100 years. The new silver dressing products take advantage of the antimicrobial benefits of the silver ions without the negative limitations of the older products. They act as an effective antimicrobial barrier to prevent infectious organisms from entering the wound. The evidence indicates that candidacy for this intervention would be a clean acute wound or burn because chronic wounds are colonized with bacteria.⁸ Silver release dressings come from different manufacturers in different formats for releasing the silver ions. One product requires that it be kept moist with sterile water to ensure continuous release of the silver ions and ongoing antimicrobial activity. Another delivery format is with a transparent film dressing that incorporates the silver-releasing compound in the dressing adhesive, allowing the silver ions to be released at a constant rate. This group of dressings should not be used on wounds with eschar.

Ultraviolet light (UV). Recent research findings have identified UV light as a useful method of stimulating autolysis of necrotic tissues, inducing a mild inflammatory response to restart the healing cascade and as a bactericidal agent.9 In this day of antibiotic-resistant microorganisms, UV therapy offers inexpensive, quick, and effective killing of a broad spectrum of microbes.⁹

Tissue Regeneration
Tissue regeneration may be halted during any phase of wound healing. The three pharmacological agents and devices described have proven efficacy for restarting the healing cascade.

Growth factors (GF). Proteins derived from the cells of repair that have been identified as important for progression of the normal wound healing cascade, GF may not be produced adequately by the cells to stimulate the healing process. Several years ago, a process for obtaining GF from a patient's own blood was developed. Analysis of research data showed improved healing and lower amputation rates when accompanied by comprehensive wound care.1 A new product, using new DNA technology, has resulted in the production of a single human GF: becaplermin. It was the first recombinant GF to receive FDA approval in 1997. Specially approved for the treatment of lower extremity diabetic neuropathy ulcers, becaplermin has an efficacy for healing that is supported by four prospective double blind, randomized clinical trails when accompanied with good wound care and off-loading.1 The drug requires a prescription and is expensive. If a diabetic neuropathic ulcer is not a path of healing with standard good wound care, it may be cost-effective to add this new therapy to the regimen.¹

Negative pressure therapy. Negative pressure applied to a wound creates a vacuum that increases tension among adjacent cells and is believed to alter the cell shape. This type of therapy is also known as vacuum-assisted closure. Stress to the cells stimulates cell division and angiogenesis at the same time that it draws the edges toward the wound center, resulting in wound closure. The negative pressure device consists of an open cell foam dressing that is inserted in the wound cavity and then the air pressure within the wound cavity is reduced to negative pressure. The negative pressure also removes chronic wound edema, increasing local blood flow, which removes chronic wound fluid while stimulating granulation tissue formation. Several clinical and case studies have been published that support use of this type of therapy for deep recalcitrant wound healing.¹

Warming therapy. Hippocrates said that "wounds love warmth" and Winter10 demonstrated that wounds heal better in a moist environment. Biomedical engineers have designed a device that combines these two concepts into a warming and moisture-retentive dressing. Most wounds are hypothermic-averaging 5.6° F cooler than core body temperature.11 Physiologic effects of hypothermia include vasoconstriction, depressed neutrophil activity, reduced ability of the cells to use oxygen free radicals to kill bacteria, and lower levels of collagen deposition resulting in impaired host resistance to wound infection and delayed wound healing.12 With warming therapy, the wound and surrounding skin temperature is raised toward core body temperature. Several randomized controlled studies have found that pressure ulcers and venous ulcers have improved wound healing with warming therapy.¹

Rehab departments often receive referrals of refractory wounds. Having an evidenced-based protocol of treatment interventions derived from a systematic evaluative process will improve management decisions and enhance cost-effective outcomes.

Carrie Sussman, PT, is president of Sussman Physical Therapy Inc and Wound Care Management Services, Torrance, Calif, and editor of Wound Care: A Collaborative Practice Manual for Physical Therapists and Nurses and Wound Care Patient Education and Resource Manual published by Aspen Publishers, Gaithersburg, Md.

References
1. Bates-Jensen B, Edvalson J, Gary DE, et al. Management of the wound environment with advanced therapies. In: Sussman C, Bates-Jensen B, eds. Wound Care: A Collaborative Practice Manual for Physical Therapists and Nurses. 2nd ed. Gaithersburg, Md: Aspen; 2001:272-292.
2. American Physical Therapy Association. Guide to physical therapist practice. Phys Ther. 2001;81:9-744.
3. Bergstrom N, Allman RM, Alvarez OM, Bennet MA, Carlson CE, Frantz R. Clinical Practice Guideline: Treatment of Pressure Ulcers. Rockville, Md: US Department of Health and Human Services. Public Health Service Agency for Health Care Policy and Research; 1994.
4. Sackett D. Rules of evidence and clinical recommendations on the use of antithrombotic agents. Chest. 1989;95(2): 2s-4s.
5. Roma-Moore A, Bolton L, McNally A. Controlled clinical evaluations vs case studies. In: Krasner D, Rodheaver G, Sibbald G, eds. Chronic Wound Care. 3rd ed. Wayne, Pa: HMP Communications; 2001:51-61.
6. Khachemoune A, Phillips T. Cost effectiveness in wound care. In: Krasner D, Rodheaver G, Sibbald G, eds. Chronic Wound Care. 3rd ed. Wayne, Pa: HMP Communications; 2001:191-97.
7. Sussman G. Management of the wound environment. In: Sussman C, Bates-Jensen B, eds. Wound Care: A Collaborative Practice Manual for Physical Therapists and Nurses. Gaithersburg, Md: Aspen; 2001: 257-271.
8. Rodheaver G. Wound cleansing, wound irrigation, wound disinfection. In: Krasner D, Rodheaver G, Sibbald G, eds. Chronic Wound Care. 3rd ed. Wayne, Pa: HMP Communications; 2001:369-80.
9. Conner-Kerr T. Ultraviolet light and wound healing. In: Sussman C, Bates-Jensen B, eds. Wound Care: A Collaborative Practice Manual for Physical Therapists and Nurses. Gaithersburg, Md: Aspen; 2001: 580-94.
10. Winter GD. Formation of the scab and the rate of epithelialization of superficial wounds in the skin of the young domestic pig. Nature. 1962;193:293-94.
11. Bello Y, Lopez AP, Philips TJ. Wound temperature is lower than core temperature [abstract]. Presented at: Symposium for Advanced Wound Care and 8th Annual Medical Research Forum on Wound Repair; April 18-22, 1998; Miami.
12. Ikeda T, Tayefeh F, Sessler DI, et al. Local radiant heating increases subcutaneous oxygen tension. Am J Surg. 1998;175:33-37.

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November 2001