SQ53 Disinfectant Wipes for Prevention of CRBSI

SQ53 Disinfectant Wipes for Prevention of Catheter Related Blood Stream Infection in Patients Receiving Home Parenteral Nutrition: A Single Blind Randomized Placebo-controlled Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Catheter-related Bloodstream Infection
• Intervention / Treatment: Device: Ethanol Wipe; Device: SQ53 Wipe

Detailed Description

Parenteral nutrition (PN) therapy is an essential component of medical management of patients suffering from intestinal failure. Depending on the underlying etiology and the type of intestinal failure, the duration of parenteral nutrition therapy could range from several weeks to several years, although a substantial proportion of these patients also require lifelong parenteral nutrition support. These patients continue the infusion of PN at their homes and are managed by the Cleveland Clinic's Home PN support team. These patients require Central Venous Catheters (CVC) for prolonged period of time for infusion of parenteral nutrition. The two most commonly used central catheters for TPN infusion are the Peripherally Inserted Central Catheter (PICC) and Tunneled CVCs. Catheter related blood stream infection (CRBSI) is a major complication of long-term CVCs. CRBSI is associated with high morbidity, mortality and healthcare cost. Additionally, CRBSI can also lead to an interruption in nutrient delivery, loss of work and productivity, premature vascular access device removal, and poor quality of life.

Prevention of CRBSI is an important component of clinical management of patients receiving home PN therapy. Several strategies have been adopted to reduce the incidence of CRBSI. A heparin lock solution was used in the past for many years; however, current nutrition society guidelines recommend normal saline locks instead of heparin locks. Published data has suggested that heparin locks have not proven to have a substantial effect on CRBSI prevention, and it paradoxically increases the infection risk due to biofilm production. Antibiotic locks have also been used, although this practice is largely not preferred due to increased risk of infections with resistant microorganisms. Taurolidine is another lock solution which has been studied in the countries outside the United States such as Canada; however, it has not been approved for the use in the U.S. yet.1

• Study Type: Interventional
• Enrollment (Actual): 59
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ellari Hodges; Phone Number: 216 442-6652; Email: hodgese@ccf.org

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard Wipe; Participants will receive a supply of ethanol-based wipes for daily use	Device: Ethanol Wipe; Ethanol-based wipe to be used by the participant daily or upon dressing change
Experimental: SQ53 Wipe; Participants will receive a supply of SQ53 wipes for daily use.	Device: SQ53 Wipe; SQ53-based wipe to be used by the participant daily or upon dressing change

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Catheter Exchange Rates	Reduction in catheter exchange rates by participants over 1000 days	6 months

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Collaborators: JVS Products, Ltd.
• Investigators: Principal Investigator: Donald Kirby, MD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2021
• Primary Completion (Actual): December 7, 2022
• Study Completion (Actual): December 7, 2022

Study Registration Dates

• First Submitted: March 26, 2021
• First Submitted That Met QC Criteria: March 26, 2021
• First Posted (Actual): March 30, 2021

Study Record Updates

• Last Update Posted (Estimated): June 2, 2023
• Last Update Submitted That Met QC Criteria: May 5, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Infections; Physiological Effects of Drugs; Anti-Infective Agents, Local; Anti-Infective Agents; Central Nervous System Depressants; Ethanol
• Other Study ID Numbers: CC-SQ53

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No