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Sponsors and Collaborators: |
Centers for Disease Control and Prevention Procter and Gamble Ste. Croix Hospital, Leogane, Haiti |
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Information provided by: | Centers for Disease Control and Prevention |
ClinicalTrials.gov Identifier: | NCT00139100 |
Introduction. Lymphatic filariasis is a devastating mosquito-transmitted parasitic disease that causes lymphedema or elephantiasis of the leg in 15 million persons, the majority of whom are women. In these persons, frequent bacterial infections ("acute attacks") of the legs adversely affect physical health, economic well-being, and quality of life. Prevention of bacterial infections through hygiene and skin care can result in significant improvements in lymphedema and patient well-being.
Methods. To determine the extent to which antibacterial soap can help reduce the incidence of acute bacterial infections of the lower limbs in persons with filarial lymphedema, 200 patients of the Ste. Croix Hospital lymphedema treatment clinic in Leogane, Haiti randomly assigned to receive either antibacterial (Safeguard) or placebo (Camay) soap and acute attacks monitored monthly for 12 months. Both groups received specific instructions on washing and skin care.
Condition | Intervention |
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Lymphedema Cellulitis |
Drug: antimicrobial agent in soap |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Active Control, Single Group Assignment, Efficacy Study |
Official Title: | Evaluation of Antibacterial Soap for Treatment of Lymphedema and Elephantiasis in an Area Endemic for Lymphatic Filariasis |
Estimated Enrollment: | 200 |
Study Start Date: | February 2001 |
Estimated Study Completion Date: | March 2002 |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients eligible for participation include those who are currently enrolled in the lymphedema treatment program in Leogane who 1) have been trained in the techniques of self-care, 2) who live in a 10-km radius of the hospital, and 3) for whom we have adequate data on incidence of acute bacterial infections, risk factors for infection, and ability to comply with the treatment protocol (particularly hygiene).
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Exclusion Criteria: Don't meet inclusion criteria.
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Study ID Numbers: | CDC-NCID-2822 |
Study First Received: | August 29, 2005 |
Last Updated: | October 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00139100 |
Health Authority: | United States: Federal Government |
Lymphatic filariasis Elephantiasis, Filarial Skin Diseases Filariasis Nematode Infections Inflammation Lymphedema |
Lymphatic Diseases Cellulitis Skin Diseases, Infectious Connective Tissue Diseases Suppuration Parasitic Diseases Helminthiasis |
Spirurida Infections Pathologic Processes Infection Secernentea Infections |