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Clinical Trial News

Section Editor(s): Hess, Cathy Thomas BSN, RN, CWOCN


From May 1997 through November 2000, 8 (3%) of 265 kidney transplant recipients at a hospital in California developed an unusual skin condition following transplant. On clinical examination, the patients had fibrotic skin lesions histologically resembling scleromyxedema on their distal extremities and trunk, resulting in severe contractions and limited mobility. However, the usual IgG lambda paraprotein associated with scleromyxedema was not observed in these patients. Personnel in the dermato-pathology section at the University of California, San Francisco, reviewed the biopsies and concluded that this skin disorder had not been described previously. As a result, health care providers at the hospital where the index patient was treated asked the California Department of Health Services (CDHS) and the Centers for Disease Control and Prevention to assist in the investigation.

A case was defined as large areas of hardened skin with slightly raised plaques or papules, with or without pigment alteration, a patient with a skin biopsy indicating increased dermal fibroblasts and mucin, and an abnormal dermal collagen bundle pattern. As of January 2002, 49 patients have been identified throughout the United States and Europe. Although having renal disease is not part of the case definition, all patients have had underlying renal disease; approximately half have had renal transplantation. No consistently effective treatment exists; however, some patients have improved.

To identify risk factors for this condition, in February 2001, CDHS conducted a case-control study among the 8 case patients at the index hospital, all of whom had renal disease and had undergone renal transplantation. Three controls were selected per case, matched by closest renal transplant date. Case patients were found to be more likely than controls to have poor renal function following transplantation, which included requiring hemodialysis and receiving medications associated with severe disease. Because this investigation involved a small number of patients who had undergone renal transplantation, the case control study should be expanded to include other reported cases, including cases among nontransplant patients.

Clinical and histopathologic photographs of this condition are available at Information about patients with this condition can be reported to [email protected] until July 2002.

Source: MMWR. Fibrosing skin condition among patients with renal disease—United States and Europe, 1997-2002. 2002;51:25-6; originally reported in Cowper SE, Robin HS, Steinberg SM, Su LD, Gupta S, LeBoit PE. Scleromyxoedema-like cutaneous diseases in renal-dialysis patients. Lancet 2000;356: 1000–1.


Results of a pilot study, published in the January 2002 issue of The Physician and Sportsmedicine, conclude that the FemSoft Insert from Rochester Medical Corporation, Stewartville, MN, is an effective, safe, and comfortable treatment for women with exercise-induced incontinence. The study was conducted by Melissa Dunn, MD; Debra Brandt, RN; and Ingrid Nygaard, MD, of the Department of Obstetrics and Gynecology at the University of Iowa College of Medicine in Iowa City.

All women in the study had less urinary leakage while using the FemSoft Insert during their exercise activities. Median urine loss decreased from 20 grams in women not wearing the device to 2.58 grams in women wearing it. At the end of 3 months, satisfaction and comfort were rated high in surveys completed by the women.

The FemSoft Insert is a small, single-use liquid and silicone device a woman inserts into her urethra. The latex-free device consists of a soft, thin, fluid-filled silicone sleeve. As a woman inserts the device, the soft liquid sleeve easily slides into and conforms to her urethra, forming an effective seal at the neck of the bladder. It is removed during regular bathroom visits, discarded, then replaced by a fresh insert.

The FemSoft Insert is approved for sale by the U.S. Food and Drug Administration for the treatment of stress urinary incontinence.


Researchers at the University of Pennsylvania, Philadelphia, PA, found that women over 65 on hormone replacement therapy (HRT) were less likely to develop either a pressure ulcer or venous ulcer than those who did not take hormones, according to a report published in the February 23, 2002, issue of the The Lancet.

Using a case-cohort study that included elderly patients in the United Kingdom General Practice Research Database, the authors examined the records of 44,195 female patients and found that women receiving HRT were about 35% less likely to develop a pressure ulcer or venous leg ulcer. Although the authors did not address the question of whether HRT could be used to treat existing pressure or venous ulcers, they felt their results suggest that it could, based on the principle that prevention of these ulcers is probably a good marker of healing. In fact, the standard treatment for these wounds—compression for a venous ulcer and pressure relief for a pressure ulcer—is the same as that for prevention.

The study was funded by the National Institute of Arthritis, Muscular, Skeletal and Skin Disease, which is part of the National Institutes of Health.

Source: Margolis DJ, Knauss J, Bilker W. Hormone replacement therapy and prevention of pressure ulcers and venous leg ulcers. Lancet 2002; 359:675-77.

© 2002 Lippincott Williams & Wilkins, Inc.