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

• Sponsor: Centers for Disease Control and Prevention (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT00139100
• Collaborator: Procter and Gamble (Industry), Ste. Croix Hospital, Leogane, Haiti (Other)
• Enrollment: 200
• Location: 1
• Duration (Months): 12.9
• Patients Per Site Per Month: 15.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lymphedema; Cellulitis	Drug: antimicrobial agent in soap	N/A

Study Design

• Study Type: Interventional
• 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
• Study Start Date: Feb 1, 2001
• Study Completion Date: Mar 1, 2002

Outcome Measures

Primary Outcome Measures

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

2. Reported or observed severity of these acute attacks. []

3. Duration of acute attacks. []

Secondary Outcome Measures

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. []

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• 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).

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Exclusion Criteria: Don't meet inclusion criteria.

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Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hopital Ste. Croix	Leogane		Haiti

Sponsors and Collaborators

• Centers for Disease Control and Prevention
• Procter and Gamble
• Ste. Croix Hospital, Leogane, Haiti

Investigators

• Principal Investigator: David G Addiss, MD, CDC/NCID/DPD

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00139100
• Other Study ID Numbers: CDC-NCID-2822
• First Posted: Aug 31, 2005
• Last Update Posted: Oct 24, 2008
• Last Verified: Aug 1, 2005

• Additional relevant MeSH terms: Cellulitis; Filariasis; Lymphedema; Anti-Infective Agents; Anti-Bacterial Agents

Study Results

No Results Posted as of Oct 24, 2008