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Completed

NCT Number: NCT00139100

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

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.

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Key information

Conditions

Lymphedema Cellulitis Connective Tissue Diseases Hemic and Lymphatic Diseases Infections Inflammation Lymphatic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases, Infectious Skin and Connective Tissue Diseases Suppuration

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hopital Ste. Croix

Léogâne, Haiti

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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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Treatment and study plan

antimicrobial agent in soap

Drug

Primary outcomes

  1. Incidence of bacterial "acute attacks", assessed monthly.

  2. Reported or observed severity of these acute attacks.

  3. Duration of acute attacks.

Secondary outcomes

  1. Process measures

  2. Number of bars of soap used per patient per month.

  3. Demonstrated knowledge and ability to wash leg appropriately during home visits.

  4. Reported patient satisfaction with soap.

  5. Reported frequency of leg washing.

Sponsors and collaborators

Lead sponsor

Centers for Disease Control and Prevention

Fed

Collaborators

  • Procter and Gamble
  • Ste. Croix Hospital, Leogane, Haiti

Registry information

Official study title

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

Important dates

Study start
2001
Study completion
2002
First posted
Aug 31, 2005
Registry last updated
Oct 24, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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