An interventional study of antimicrobial agent in soap in Lymphedema and Cellulitis, sponsored by Centers for Disease Control and Prevention. Completed at 1 site in Haiti. Per ClinicalTrials.gov, last updated 2008-10-24.
Sponsored by Centers for Disease Control and Prevention · Not applicable, Interventional, and Prevention
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.
529 studies on the registry are indexed under Lymphedema; 131 are open to participants now.
This study's enrollment of 200 is above the median of 50 across 369 interventional studies indexed under Lymphedema.
Browse Lymphedema studies →Centers for Disease Control and Prevention is the lead sponsor of 275 studies on the registry; 2 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 8 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
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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Incidence of bacterial "acute attacks", assessed monthly.
Reported or observed severity of these acute attacks.
Duration of acute attacks.
Process measures
Number of bars of soap used per patient per month.
Demonstrated knowledge and ability to wash leg appropriately during home visits.
Reported patient satisfaction with soap.
Reported frequency of leg washing.
The record gives a start of Feb 2001 and a completion of Mar 2002. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2005. You cannot join it, but the record below documents what was studied.
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