Evaluation of Antibacterial Soap for Treatment of Lymphedema in a Filariasis-Endemic Area
Primary Purpose
Lymphedema, Cellulitis
Status
Completed
Phase
Not Applicable
Locations
Haiti
Study Type
Interventional
Intervention
antimicrobial agent in soap
Sponsored by
About this trial
This is an interventional prevention trial for Lymphedema
Eligibility 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). - Exclusion Criteria: Don't meet inclusion criteria. -
Sites / Locations
- Hopital Ste. Croix
Outcomes
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.
Full Information
NCT ID
NCT00139100
First Posted
August 29, 2005
Last Updated
October 23, 2008
Sponsor
Centers for Disease Control and Prevention
Collaborators
Procter and Gamble, Ste. Croix Hospital, Leogane, Haiti
1. Study Identification
Unique Protocol Identification Number
NCT00139100
Brief Title
Evaluation of Antibacterial Soap for Treatment of Lymphedema in a Filariasis-Endemic Area
Official Title
Evaluation of Antibacterial Soap for Treatment of Lymphedema and Elephantiasis in an Area Endemic for Lymphatic Filariasis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2005
Overall Recruitment Status
Completed
Study Start Date
February 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2002 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Centers for Disease Control and Prevention
Collaborators
Procter and Gamble, Ste. Croix Hospital, Leogane, Haiti
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphedema, Cellulitis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
200 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
antimicrobial agent in soap
Primary Outcome Measure Information:
Title
Incidence of bacterial "acute attacks", assessed monthly.
Title
Reported or observed severity of these acute attacks.
Title
Duration of acute attacks.
Secondary Outcome Measure Information:
Title
Process measures
Title
Number of bars of soap used per patient per month.
Title
Demonstrated knowledge and ability to wash leg appropriately during home visits.
Title
Reported patient satisfaction with soap.
Title
Reported frequency of leg washing.
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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).
-
Exclusion Criteria: Don't meet inclusion criteria.
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David G Addiss, MD
Organizational Affiliation
CDC/NCID/DPD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Ste. Croix
City
Leogane
Country
Haiti
12. IPD Sharing Statement
Citations:
PubMed Identifier
20850849
Citation
Addiss DG, Michel MC, Michelus A, Radday J, Billhimer W, Louis-Charles J, Roberts JM, Kramp K, Dahl BA, Keswick B. Evaluation of antibacterial soap in the management of lymphoedema in Leogane, Haiti. Trans R Soc Trop Med Hyg. 2011 Jan;105(1):58-60. doi: 10.1016/j.trstmh.2010.08.011. Epub 2010 Sep 17.
Results Reference
derived
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Evaluation of Antibacterial Soap for Treatment of Lymphedema in a Filariasis-Endemic Area
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