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

Tracking Information

First Received Date ^ICMJE

August 29, 2005

Last Updated Date

October 23, 2008

Start Date ^ICMJE

February 2001

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Incidence of bacterial "acute attacks", assessed monthly.
Reported or observed severity of these acute attacks.
Duration of acute attacks.

Original Primary Outcome Measures ^ICMJE

Incidence of bacterial “acute attacks”, assessed monthly.
Reported or observed severity of these acute attacks.
Duration of acute attacks.

Change History

Complete list of historical versions of study NCT00139100 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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.

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Double-Blind, Active Control, Single Group Assignment, Efficacy Study

Condition ^ICMJE

Lymphedema
Cellulitis

Intervention ^ICMJE

Drug: antimicrobial agent in soap

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

200

Completion Date

March 2002

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Haiti

Administrative Information

NCT ID ^ICMJE

NCT00139100

Responsible Party

Study ID Numbers ^ICMJE

CDC-NCID-2822

Study Sponsor ^ICMJE

Centers for Disease Control and Prevention

Collaborators ^ICMJE

Procter and Gamble
Ste. Croix Hospital, Leogane, Haiti

Investigators ^ICMJE

Principal Investigator:

David G Addiss, MD

CDC/NCID/DPD

Information Provided By

Centers for Disease Control and Prevention

Verification Date

August 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP