Arterial Bypass Graft SurgeryNCT03534388
A Feasibility Study to Evaluate Skin Cleansing With a Sodium Hypochlorite Wash
A study testing Sodium Hypochlorite Cleanser in people with Arterial Bypass Graft Surgery, run by TopMD Skin Care, Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arterial Bypass Graft Surgery
- What is being tested?
- Sodium Hypochlorite Cleanser
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 10 May 2018to 1 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.)
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Arterial Bypass Graft Surgery
- Being tested
- Sodium Hypochlorite Cleanser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium Hypochlorite CleanserOther
Cleansing with CLn BodyWash
| Study group | Role | What they receive |
|---|---|---|
| Prospective Subjects | Other | Not described Receives: Other: Sodium Hypochlorite Cleanser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in percentage
Fewer infected patients than in the retrospective data
Measured: 5 week per subject
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2018
- Study start10 May 2018
- Primary completion1 Jul 2019 (estimated)
- Study completion1 Dec 2019 (estimated)
Why it stopped: Enrollment difficulty
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arterial Bypass Graft SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Feasibility comparing to retrospective data.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- TopMD Skin Care, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stephen E Hohmann, MD, Principal investigator, Texas Vascular Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03534388
- Sponsor's protocol ID
- CLN 004.2
- Status last verified
- May 2018
- First submitted
- 30 Nov 2017
- Last updated
- 25 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03534388
- Acronym / sponsor ID
- CLN 004.2
- Conditions
- Arterial Bypass Graft Surgery
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Enrollment difficulty
- Enrolment
- 0 participants (actual)
- Lead sponsor
- TopMD Skin Care, Inc.Industry (pharma, biotech, devices)
- Study start
- 10 May 2018 (actual)
- Primary completion
- 1 Jul 2019 (estimated)
- Study completion
- 1 Dec 2019 (estimated)
- First posted
- 23 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Feasibility comparing to retrospective data.
| Arm | Type | Receives |
|---|---|---|
| Prospective Subjects | Other | Other: Sodium Hypochlorite Cleanser |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.)
Key exclusion criteria (3 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium Hypochlorite CleanserCleansing with CLn BodyWash | Other | Prospective Subjects |
Primary outcome
Decrease in percentage
Time frame: 5 week per subject
Fewer infected patients than in the retrospective data
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen E Hohmann, MD principal investigator
Texas Vascular Associates
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sodium Hypochlorite Cleanser in people with Arterial Bypass Graft Surgery, run by TopMD Skin Care, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 25 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease in percentage (time frame: 5 week per subject). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2019.