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SQ53 Disinfectant Wipes for Prevention of CRBSI

NCT04822467 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2023-06-02

Study results available
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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.

Conditions

  • Catheter-related Bloodstream Infection

Interventions

DEVICE

SQ53 Wipe

SQ53-based wipe to be used by the participant daily or upon dressing change

DEVICE

Ethanol Wipe

Ethanol-based wipe to be used by the participant daily or upon dressing change

Sponsors & Collaborators

  • JVS Products, Ltd.

    collaborator UNKNOWN

  • The Cleveland Clinic

    lead OTHER

Principal Investigators

  • Donald Kirby, MD · The Cleveland Clinic

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-10
Primary Completion
2022-12-07
Completion
2022-12-07
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04822467 on ClinicalTrials.gov