SQ53 Disinfectant Wipes for Prevention of CRBSI

NCT04822467 | Completed Results FDA Device

• 1 other identifier: CC-SQ53
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Number of Catheter-Related Blood Stream Infections (CRBSI) at 6 Months

  Reduction in the number of CRBSI experienced by participants over a six month period (1000 days)

  6 months

Secondary Outcomes (1)

• Catheter Exchange Rates

  6 months

Study Arms (2)

Standard Wipe

ACTIVE COMPARATOR

Participants will receive a supply of ethanol-based wipes for daily use

Device: Ethanol Wipe

SQ53 Wipe

EXPERIMENTAL

Participants will receive a supply of SQ53 wipes for daily use.

Device: SQ53 Wipe

Interventions

SQ53 Wipe DEVICE

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

SQ53 Wipe

Ethanol Wipe DEVICE

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

Standard Wipe

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients requiring home parenteral nutrition support via PICC line or tunneled CVC.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Cleveland Clinic: lead
• JVS Products, Ltd.: collaborator

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Results Point of Contact

• Title: Dr. Donald Kirby, MD
• Organization: Cleveland Clinic Foundation

kirbyd@ccf.org

216-444-0446

Study Officials

• Donald Kirby, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 26, 2021
• First Posted: March 30, 2021
• Study Start: December 10, 2021
• Primary Completion: December 7, 2022
• Study Completion: December 7, 2022
• Last Updated: June 2, 2023
• Results First Posted: June 2, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)