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

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

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
Intervention Model: Single Group Assignment
Masking: Double
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

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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Please refer to this study by its identifier: NCT00139100

Hopital Ste. Croix
Leogane, Haiti
Sponsors and Collaborators
Centers for Disease Control and Prevention
Procter and Gamble
Ste. Croix Hospital, Leogane, Haiti
Principal Investigator: David G Addiss, MD CDC/NCID/DPD
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00139100     History of Changes
Other Study ID Numbers: CDC-NCID-2822
Study First Received: August 29, 2005
Last Updated: October 23, 2008

Additional relevant MeSH terms:
Lymphatic Diseases
Skin Diseases, Infectious
Connective Tissue Diseases
Pathologic Processes
Spirurida Infections
Secernentea Infections
Nematode Infections
Parasitic Diseases
Anti-Infective Agents
Anti-Bacterial Agents processed this record on August 18, 2017