A Feasibility Study to Evaluate Skin Cleansing With a Sodium Hypochlorite Wash

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Feasibility Study to Evaluate a Skin Cleansing Regimen With a Sodium Hypochlorite Wash in Lower Extremity Arterial Bypass Graft Surgery or Femoral Endarterectomy

Conditions
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Arterial Bypass Graft Surgery

Intervention / Treatment
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* Other: Sodium Hypochlorite Cleanser


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is male or female greater than the age of 18 years. Subject is willing and able to give written informed consent and to comply with the requirements of the study. Subject has 5 or more days of time prior to elective surgery scheduled to sign consent and begin washing parameters. 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.)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: Feasibility comparing to retrospective data.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Prospective Subjects<br> | Other: Sodium Hypochlorite Cleanser<br>* Cleansing with CLn BodyWash<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease in percentage | Fewer infected patients than in the retrospective data | 5 week per subject |