Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04822467 |
| Other study ID # |
CC-SQ53 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 10, 2021 |
| Est. completion date |
December 7, 2022 |
Study information
| Verified date |
May 2023 |
| Source |
The Cleveland Clinic |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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
