Cellulitis, Lymphedema
Conditions
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.
Interventions
DRUGantimicrobial agent in soap
Sponsors
Procter and Gamble
Ste. Croix Hospital, Leogane, Haiti
Centers for Disease Control and Prevention
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
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). \-
Exclusion criteria
Don't meet inclusion criteria. \-
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of bacterial acute attacks, assessed monthly. | — |
| Reported or observed severity of these acute attacks. | — |
| Duration of acute attacks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Demonstrated knowledge and ability to wash leg appropriately during home visits. | — |
| Reported patient satisfaction with soap. | — |
| Process measures | — |
| Number of bars of soap used per patient per month. | — |
| Reported frequency of leg washing. | — |
Countries
Haiti
Outcome results
None listed