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

Arterial Bypass Graft Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03534388
• Other study ID #: CLN 004.2
• Status: Withdrawn
• Phase: N/A
• Start date: May 10, 2018
• Est. completion date: December 1, 2019

Study information

• Verified date: May 2018
• Source: TopMD Skin Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 1, 2019
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.)

Related Conditions & MeSH terms

• Arterial Bypass Graft Surgery

Intervention

Other:
• Sodium Hypochlorite Cleanser
Cleansing with CLn BodyWash

Locations

Country	Name	City	State
United States	Texas Vascular Associates, PA	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
TopMD Skin Care, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decrease in percentage	Fewer infected patients than in the retrospective data	5 week per subject