Evaluation of Antibacterial Soap for Treatment of Lymphedema in a Filariasis-Endemic Area
Summary
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.
Study Design
Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Prevention
Conditions
Lymphedema
Intervention
antimicrobial agent in soap
Location
Hopital Ste. Croix
Leogane
Haiti
Status
Completed
Source
Centers for Disease Control and Prevention
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00139100
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Lymphangiosarcoma
A malignant tumor originating from the endothelial cells of lymphatic vessels. Most lymphangiosarcomas arise in an arm secondary to radical mastectomy but they sometimes complicate idiopathic lymphedema. The lymphedema has usually been present for 6 to 10 years before malignant changes develop. (From Dorland, 27th ed; Holland et al., Cancer Medicine, 3d ed, p1866)
Disk Diffusion Antimicrobial Tests
A method where a culturing surface inoculated with microbe is exposed to small disks containing known amounts of a chemical agent resulting in a zone of inhibition (usually in millimeters) of growth of the microbe corresponding to the susceptibility of the strain to the agent.
Ronidazole
Antiprotozoal and antimicrobial agent used mainly in veterinary practice.
Sulfaguanidine
A sulfanilamide antimicrobial agent that is used to treat enteric infections.
Sulfamethazine
A sulfanilamide anti-infective agent. It has a spectrum of antimicrobial action similar to other sulfonamides.
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