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Pressure Ulcer Healing

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  • Food or dietary treatment counteracting pressure ulcers; this is important. Getting the patient moving and increasing blood flow are important, too. Heel decubitus and bed sores are caused by lack of movement. Multi Podus type boots will prevent and alleviate pressure ulcers at the heels. LEEDer Group makes one of the best boots available: KYDEX-PRO, THE Multi Podus Boot Orthosis
Clinical Trials Show 96% Improvement In Pressure Ulcer Healing Among Nursing Home Residents

Main Category: Complementary Medicine / Alternative Medicine News
Article Date: 11 Mar 2006 – 1:00am (PST)

Medical Nutrition USA, Inc., (MDNU) announced today the results of a clinical trial on its Pro-Stat® modular protein supplement. In the first clinical trial of its kind, investigators found that the use of Pro-Stat®, improves the healing of pressure ulcers among long-term care residents by 96%.

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® 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.

“A pressure ulcer can form literally overnight, or in a matter of hours if there is unrelenting pressure in a vulnerable area,” said Mary Jane Maloney, a nurse practitioner and certified wound specialist, and a consultant to many long-term care facilities in northeastern Ohio.

Pressure ulcers usually develop over bony prominences of the body in such areas as the sacrum, hips, ankles, heels and toes and are classified into four stages: Stage I — an observable redness of the skin; Stage II — an observable thinning of the skin; Stage III — an observable thinning and skin loss with damage to the underlying tissue appearing as a deep crater or blister; and Stage IV — full skin loss with extensive damage to the skin and underlying tissue, involving necrosis (rotting of the skin) and possible damage to the muscle and bone “In the later stages, the patient is much more susceptible to infection,” said Maloney. “Patients with a deteriorating pressure ulcer usually develop sepsis. An example is the actor Christopher Reeve, who died of sepsis secondary from a large pressure ulcer.”

Usual treatment for pressure ulcers includes a range of moist wound healing modalities, patient rotation and pressure relief, topical ointments, and nutritional and/or protein supplementation.

“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.”

Pro-Stat®, is manufactured by Medical Nutrition USA, Inc., Englewood, NJ, and provides 15 grams of concentrated protein and 101 calories in one fluid ounce.

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® three times daily.

A conference call will be held on Tuesday, March 14, 2006 at 2:00 PM EST with the authors of the study. The call may be accessed by calling 1-877-407-6180 prior to the conference. Replays of the call will also be available on the http://www.pro-stat.info website until June 14, 2006 in the Investor Relations section.

FACTS/FIGURES ABOUT PRESSURE ULCERS

The Incidence and Cost

  • It has been estimated that as many as 23.9% of residents in skilled care and nursing home facilities develop pressure ulcers at some time (The National Pressure Ulcer Advisory Panel; The Agency for Health Care Policy and Research)
  • In high-risk patients, including elderly individuals with femoral fractures and/or hip fractures, the incidence and prevalence is over 60% (The National Pressure Ulcer Advisory Panel, Agency for Health Care Policy and Research)
  • In addition, an estimated 9% to 13% of patients admitted to acute care hospitals develop pressure ulcers. (J Advance Nursing)
  • 1.8 million American are annually afflicted with pressure ulcers at a treatment cost of $1.3 billion (The National Pressure Ulcer Advisory Panel)
  • 95% of pressure ulcers occur on the lower part of the body, 36% of which are on the sacrum (lower back) and 30% on the heel. (Advanced Wound Care; National Symposium on the Care, Treatment and Prevention of Decubitus Ulcers)
  • 8% of all deaths in nursing homes are attributed to pressure ulcers (J Chronic Disease)
  • 70% occur in people 70 years and older (Lancet)
  • A resident at risk can develop a pressure ulcer within 2-6 hours of the onset of pressure

Litigation

  • More than 17,000 lawsuits are related to pressure ulcers annually, the second most common claim after wrongful death and greater than falls or emotional distress (Leila C. Knox 2004; Mayo Foundation for Education and Research)
  • Individual settlements range from under $50,000 to as much as $4 million (Mayo Clinic Rochester Geriatric Medicine, Community Internal Medicine Division)
  • In 28 out of 30 plaintiff verdicts/settlements in pressure ulcer lawsuits, the average compensation was just under $1 million. (Rowe 1999)

Initiatives

  • In 2000, the US Health and Human Services Department’s Healthy People 2010 initiative established a goal of reducing the proportion of nursing home residents with pressure ulcers by 50% by 2010.
  • In 2005, US Centers for Medicare/Medicaid Services (CMS) issued updated guidance for surveyors regarding F Tag 314/Pressure Ulcers.

Medical Nutrition USA, Inc.
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