A Feasibility Study to Evaluate Skin Cleansing With a Sodium Hypochlorite Wash (NCT03534388)

Study 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.

Read the 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.

Conditions studied

Arterial Bypass Graft Surgery

In context

Lead sponsor

TopMD Skin Care, Inc. is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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

Exclusion Criteria:

1. Subject is on antibiotics prior to surgery.
  1. Subject is unable to maintain washing regimen for the full study term.
  1. 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.)

Study design

Phase: Not applicable
Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 0 participants (actual)

Study arms

Other
Prospective Subjects
Other: Sodium Hypochlorite Cleanser

Interventions

OtherSodium Hypochlorite Cleanser
Cleansing with CLn BodyWash

What researchers measure

Primary outcomes

Decrease in percentage
Fewer infected patients than in the retrospective data
Time frame: 5 week per subject

Study locations

1 site

Texas Vascular Associates, PA
Dallas, Texas 75226, United States

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 25, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03534388
Lead sponsor: TopMD Skin Care, Inc.
Responsible party: Sponsor
First posted: May 23, 2018
Start date: May 10, 2018
Primary completion: Jul 1, 2019 (estimated)
Completion: Dec 1, 2019 (estimated)
Last update: Sep 25, 2019

Study contacts

Stephen E Hohmann, MD

principal investigator · Texas Vascular Associates

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in May 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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