Arterial Bypass Graft Surgery
Conditions
Brief summary
Feasibility study in approximately 20 subjects to investigate the rate of infection with subjects undergoing elective lower extremity arterial bypass graft surgery or femoral endarterectomy. The subjects are instructed to shower with the sodium hypochlorite body wash daily, or as modified by the physician, for 5 of the 7 days leading to their surgery.
Detailed description
This is a feasibility study in approximately 20 subjects over a 5-week period per subject. The study will investigate the rate of infection with subjects undergoing elective lower extremity arterial bypass graft surgery or femoral endarterectomy. The subjects are instructed to shower with the sodium hypochlorite body wash daily, or as modified by the physician, for 5 of the 7 days leading to their surgery.
Interventions
OTHERSodium Hypochlorite Cleanser
Cleansing with CLn BodyWash
Sponsors
TopMD Skin Care, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Feasibility comparing to retrospective data.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject is male or female greater than the age of 18 years. 2. Subject is willing and able to give written informed consent and to comply with the requirements of the study. 3. Subject has 5 or more days of time prior to elective surgery scheduled to sign consent and begin washing parameters. 4. Subject is capable of taking a shower and lathering their entire body, or is able to be helped by a caregiver to shower each day with lather on their entire body for 5 out of 7 days immediately prior to elective surgery. (Modifications for bath usage can be made by the physician if the result of the product being left on the skin of the entire body for the time commitment is maintained, and if the body can be rinsed with poured water. Bed bath is not considered an allowable modification.)
Exclusion criteria
* 1\) Subject is on antibiotics prior to surgery. 2\) Subject is unable to maintain washing regimen for the full study term. 3\) Subject is unable to follow pre-surgery cleansing instructions for 5 of the 7 days immediately prior to surgery. (Bed bath is not considered a cleansing day.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Decrease in percentage | 5 week per subject | Fewer infected patients than in the retrospective data |
Countries
United States
Outcome results
None listed