Clinical Trial Shows 96% Improvement in Pressure Ulcer Healing Among Nursing Home Residents

Reported in the March 2006 issue of Advances in Skin & Wound Care, a multidisciplinary peer-reviewed journal, the multi-state, randomized, placebo-controlled trial covering 89 residents in 23 nursing homes studied the healing rates of those receiving standard care plus Pro-Stat(R) liquid protein supplement, compared with a control group receiving standard care plus a placebo. Standard care for both groups included patient-appropriate topical and pressure-relief treatments as well as enhanced foods and other supplements, including some formulated for wound healing. While both groups showed improvement, the amount of healing in the treatment group was significantly greater than in the control group.

The incidence of pressure ulcers (bedsores) is a serious problem in long- term care facilities, affecting as much as 23% of long-term care residents and costing an estimated $1.3 billion in treatment costs annually. Pressure ulcers are also one of the most common causes of litigation involving nursing homes. Additionally, pressure ulcers have become a focus issue for Federal and State health care facility regulators. After observing little improvement in pressure ulcer incidence for more than 30 years, in 2000 the US Health and Human Services department in its Healthy People 2010 initiative called for a 50% reduction in pressure ulcer incidence by 2010. In 2005, the Centers for Medicare and Medicaid Services (CMS) issued new survey guidelines for the assessment, treatment and prevention of pressure ulcers in nursing homes.

"Pressure ulcers represent a major cost for long-term care facilities in terms of treatment and potential litigation. For the resident, they can be life threatening and pose a significant lifestyle issue," said S. Kwon Lee, MD, FACS, a Cleveland physician and wound care specialist, and the principal investigator for the study. "While nutritional supplements have long been recommended to prevent or treat pressure ulcers, this is the first randomized, controlled trial to actually show how much healing occurs with different treatment regimens. I believe the findings will be very beneficial to nursing home staff and wound care specialists because they provide more information on how best to prevent and treat one of the most distressing and costly ailments afflicting long term care residents."

Defined as any lesion caused by unrelieved pressure resulting in damage to the underlying tissue, pressure ulcers, often called bedsores, are primarily caused by immobility and are particularly common among nursing home residents many of whom experience nutritional deficiencies. Inadequate protein metabolism impairs the body's ability to form new skin tissue and heal wounds. Pressure ulcers are often associated with insufficient turning and poor body alignment while the resident is confined to bed. Long periods of sitting in one position, such as in a wheelchair, can also cause the skin to breakdown. Malnutrition, dehydration, repeated skin wetting and abrasions from sheets can heighten the occurrence of pressure ulcers. A resident at risk can develop a pressure ulcer within two to six hours of the onset of pressure, making timely intervention critical.

"Data has long suggested that high protein diets improve the healing of pressure ulcers, but specific evidence until now has been weak regarding how much protein, and in what form, is most effective," said Dr. Lee. "An easily digested, easily consumed, concentrated, liquid protein, such as that used in the study, makes it easier for residents to get the amount they need. The results may also have been influenced by the fact that the study product is hydrolyzed for rapid absorption and rich in the amino acids arginine, glutamine and glycine, which have been found to improve wound healing."

A total of 89 residents with 132 total Stage II, III or IV pressure ulcers in 23 nursing homes in New York, New Jersey, Ohio and Indiana were included in the eight-week study. The treatment group received 1.5 ounces of Pro-Stat(R) three times daily.

For more information regarding Pro-Stat, contact CWI Medical toll-free at 1-877-9-CWIMED or at the company's website - www.cwimedical.com. CWI Medical is a privately held company located in Farmingdale, New York that services and distributes medical supplies and health care products.

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