Evaluation of Antibacterial Soap for Treatment of Lymphedema in a Filariasis-Endemic Area

Lymphedema Clinical Trial

Official title:

Evaluation of Antibacterial Soap for Treatment of Lymphedema and Elephantiasis in an Area Endemic for Lymphatic Filariasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00139100
• Other study ID #: CDC-NCID-2822
• Status: Completed
• Phase: N/A
• First received: August 29, 2005
• Last updated: October 23, 2008
• Start date: February 2001
• Est. completion date: March 2002

Study information

• Verified date: August 2005
• Source: Centers for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: March 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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).

Exclusion Criteria: Don't meet inclusion criteria.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cellulitis
• Filariasis
• Lymphedema

Intervention

Drug:
• antimicrobial agent in soap

Locations

Country	Name	City	State
Haiti	Hopital Ste. Croix	Leogane

Sponsors (3)

Lead Sponsor	Collaborator
Centers for Disease Control and Prevention	Procter and Gamble, Ste. Croix Hospital, Leogane, Haiti

Country where clinical trial is conducted

Haiti, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of bacterial "acute attacks", assessed monthly.
Primary	Reported or observed severity of these acute attacks.
Primary	Duration of acute attacks.
Secondary	Process measures
Secondary	Number of bars of soap used per patient per month.
Secondary	Demonstrated knowledge and ability to wash leg appropriately during home visits.
Secondary	Reported patient satisfaction with soap.
Secondary	Reported frequency of leg washing.