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

TopMD, Inc.

Status

Withdrawn

Conditions

Arterial Bypass Graft Surgery

Treatments

Other: Sodium Hypochlorite Cleanser

Study type

Interventional

Funder types

Industry

Identifiers

NCT03534388

CLN 004.2

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.)