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

This study has been completed.
Sponsor:
Collaborators:
Procter and Gamble
Ste. Croix Hospital, Leogane, Haiti
Information provided by:
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT00139100
First received: August 29, 2005
Last updated: October 23, 2008
Last verified: August 2005
  Purpose

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 Intervention
Lymphedema
Cellulitis
Drug: antimicrobial agent in soap

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Evaluation of Antibacterial Soap for Treatment of Lymphedema and Elephantiasis in an Area Endemic for Lymphatic Filariasis

Resource links provided by NLM:


Further study details as provided by Centers for Disease Control and Prevention:

Primary Outcome Measures:
  • Incidence of bacterial "acute attacks", assessed monthly.
  • Reported or observed severity of these acute attacks.
  • Duration of acute attacks.

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 200
Study Start Date: February 2001
Estimated Study Completion Date: March 2002
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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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  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00139100

Locations
Haiti
Hopital Ste. Croix
Leogane, Haiti
Sponsors and Collaborators
Procter and Gamble
Ste. Croix Hospital, Leogane, Haiti
Investigators
Principal Investigator: David G Addiss, MD CDC/NCID/DPD
  More Information

No publications provided by Centers for Disease Control and Prevention

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00139100     History of Changes
Other Study ID Numbers: CDC-NCID-2822
Study First Received: August 29, 2005
Last Updated: October 23, 2008
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Cellulitis
Elephantiasis, Filarial
Filariasis
Elephantiasis
Lymphedema
Skin Diseases, Infectious
Infection
Suppuration
Connective Tissue Diseases
Inflammation
Pathologic Processes
Spirurida Infections
Secernentea Infections
Nematode Infections
Helminthiasis
Parasitic Diseases
Lymphatic Diseases
Anti-Infective Agents
Anti-Bacterial Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 26, 2014