SQ53 Disinfectant Wipes for Prevention of CRBSI (NCT04822467) | Clinical Trial Compass
CompletedNot Applicable
SQ53 Disinfectant Wipes for Prevention of CRBSI
United States59 participantsStarted 2021-12-10
Plain-language summary
SQ53 is a novel antimicrobial, sporicidal solution that is based on a platform of quaternary ammonium chloride compounds. It has been tested against a wide range of bacteria, viruses, spores and fungal pathogens. Extensive laboratory testing has demonstrated the effectiveness of SQ53 impregnated wipes in cleaning surfaces including catheters over a 24 hour plus time period. SQ53 also received an in vitro evaluation of the irritancy potential using a tissue engineered human skin model and was found to have no potential for skin irritation. SQ53 is available as a sterilized pack with a single wipe inside. The pack is easy to open by tearing off the top end and presenting the contents to the operator to remove under sterile conditions.
The current study will be a randomized single-blinded placebo-controlled clinical trial for SQ53 wipes intended for catheter cleaning in patients receiving home parenteral nutrition.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients requiring home parenteral nutrition support via PICC line or tunneled CVC.
Exclusion Criteria:
* Age less than 18 years
* Women known to be pregnant
* Women of childbearing age who are planning a pregnancy
* Women who are breastfeeding
* Patients who will not be managed by Cleveland Clinic HPN service
* Patients who refuse to use disinfectant wipes daily.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Catheter-Related Blood Stream Infections (CRBSI) at 6 Months