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

NCT03534388 | Withdrawn

• 1 other identifier: CLN 004.2
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Arterial Bypass Graft Surgery

Outcome Measures

Primary Outcomes (1)

• Decrease in percentage

  Fewer infected patients than in the retrospective data

  5 week per subject

Study Arms (1)

Prospective Subjects

OTHER

Other: Sodium Hypochlorite Cleanser

Interventions

Sodium Hypochlorite Cleanser OTHER

Cleansing with CLn BodyWash

Prospective Subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.)

You may not qualify if:

• \) Subject is on antibiotics prior to surgery.
• \) Subject is unable to maintain washing regimen for the full study term.
• \) 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.)

Sponsors & Collaborators

• TopMD Skin Care, Inc.: lead

Study Sites (1)

Texas Vascular Associates, PA

Dallas, Texas, 75226, United States

Location

Study Officials

• Stephen E Hohmann, MD

  Texas Vascular Associates

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Feasibility comparing to retrospective data.

Study Record Dates

• First Submitted: November 30, 2017
• First Posted: May 23, 2018
• Study Start: May 10, 2018
• Primary Completion: July 1, 2019
• Study Completion: December 1, 2019
• Last Updated: September 25, 2019

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)