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| Name | Class |
|---|---|
| Procter and Gamble | INDUSTRY |
| Ste. Croix Hospital, Leogane, Haiti | UNKNOWN |
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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| antimicrobial agent in soap | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of bacterial "acute attacks", assessed monthly. | ||
| Reported or observed severity of these acute attacks. | ||
| Duration of acute attacks. |
| Measure | Description | Time Frame |
|---|---|---|
| Process measures | ||
| Number of bars of soap used per patient per month. | ||
| Demonstrated knowledge and ability to wash leg appropriately during home visits. |
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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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| Name | Affiliation | Role |
|---|---|---|
| David G Addiss, MD | CDC/NCID/DPD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Ste. Croix | Léogâne | Haiti |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20850849 | Derived | 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. |
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| ID | Term |
|---|---|
| D008209 | Lymphedema |
| D002481 | Cellulitis |
| ID | Term |
|---|---|
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D012874 | Skin Diseases, Infectious |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000890 | Anti-Infective Agents |
| D012915 | Soaps |
| ID | Term |
|---|---|
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D003902 | Detergents |
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| Reported patient satisfaction with soap. |
| Reported frequency of leg washing. |
| D013492 |
| Suppuration |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013501 |
| Surface-Active Agents |
| D020313 | Specialty Uses of Chemicals |
| D006795 | Household Products |
| D013676 | Technology, Industry, and Agriculture |