N/A N=59 Randomized Single-blind Prevention

SQ53 Disinfectant Wipes for Prevention of CRBSI

Catheter-related Bloodstream Infection

Bottom Line

View on ClinicalTrials.gov: NCT04822467 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2023

Primary outcome: Primary: Number of Catheter-Related Blood Stream Infections (CRBSI) at 6 Months — 1.98; 2.09; 1.73; 1.02 Infections per 1000 days with catheter

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: SQ53 Wipe (Device); Ethanol Wipe (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: The Cleveland Clinic
Primary completion: Dec 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Catheter-Related Blood Stream Infections (CRBSI) at 6 Months	1.98; 2.09; 1.73; 1.02	—
SECONDARY Catheter Exchange Rates	1.41; 1.61; 1.26; 0.68	—

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04822467). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.