- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00139100
Evaluation of Antibacterial Soap for Treatment of Lymphedema in a Filariasis-Endemic Area
Evaluation of Antibacterial Soap for Treatment of Lymphedema and Elephantiasis in an Area Endemic for Lymphatic Filariasis
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Leogane, Haiti
- Hopital Ste. Croix
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Incidence of bacterial "acute attacks", assessed monthly.
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Reported or observed severity of these acute attacks.
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Duration of acute attacks.
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Secondary Outcome Measures
Outcome Measure |
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Process measures
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Number of bars of soap used per patient per month.
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Demonstrated knowledge and ability to wash leg appropriately during home visits.
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Reported patient satisfaction with soap.
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Reported frequency of leg washing.
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Collaborators and Investigators
Investigators
- Principal Investigator: David G Addiss, MD, CDC/NCID/DPD
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Infections
- Lymphatic Diseases
- Inflammation
- Connective Tissue Diseases
- Parasitic Diseases
- Skin Diseases, Infectious
- Suppuration
- Spirurida Infections
- Secernentea Infections
- Nematode Infections
- Helminthiasis
- Lymphedema
- Cellulitis
- Filariasis
- Anti-Bacterial Agents
- Anti-Infective Agents
Other Study ID Numbers
- CDC-NCID-2822
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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