Evaluation of Antibacterial Soap for Treatment of Lymphedema in a Filariasis-Endemic Area
|ClinicalTrials.gov Identifier: NCT00139100|
Recruitment Status : Completed
First Posted : August 31, 2005
Last Update Posted : October 24, 2008
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 or disease||Intervention/treatment|
|Lymphedema Cellulitis||Drug: antimicrobial agent in soap|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||Evaluation of Antibacterial Soap for Treatment of Lymphedema and Elephantiasis in an Area Endemic for Lymphatic Filariasis|
|Study Start Date :||February 2001|
|Estimated Study Completion Date :||March 2002|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00139100
|Hopital Ste. Croix|
|Principal Investigator:||David G Addiss, MD||CDC/NCID/DPD|