Arrow Chloragard Peripherally-Inserted Central Catheters (PICC) Study

Teleflex

Status: Unknown

Conditions: Vascular Access Complication; Vascular Access Related Infection

Treatments: Device: Arrow PICC with Chloragard Technology

Study type: Interventional

Funder types: Industry

Identifiers

NCT03019302

2015-07

Details and patient eligibility

About

A prospective study evaluating the timing, incidence and relationship of commonly occurring complications related to the use of peripherally-inserted central catheters. All subjects will receive PICC access using the Arrow PICC with Chloragard Technology.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients age ≥ 18 years requiring a PICC for a period of fourteen days or greater (note: maximum study period is 90 days)
• Ability to comply with study requirements inclusive of the follow-up duplex ultrasound procedures and, as applicable, recording of PICC management, interventions and related treatments in the inpatient and outpatient setting in the daily subject diary
• Patients cognitively and physically able to give written consent to participate in the study or patient has a legally authorized representative (LAR) who may give written consent to participate in the study

Exclusion criteria

• Previous history of (within 3 months) or current diagnosis of venous thrombosis within the venous tract of the proposed catheter
• History or diagnosis of peripheral or central vein stenosis (on proposed insertion side)
• History or diagnosis of veno-occlusive disease
• History or diagnosis of superior vena cava syndrome
• Known, pre-existing diagnosis of hypercoagulation disorder unrelated to underlying disease
• Previous enrollment in this study
• Currently pregnant or breast feeding
• Previous axillary lymph node dissection on the same side as intended catheter insertion site unless cleared by physician and patient consent
• Skin condition at or within 15 cm of the proposed catheter insertion site, including signs and symptoms of inflammation, rash, crusts, wounds with drainage, sites of intravenous infusion infiltration or extravasation, hematoma, phlebitis and or thrombophlebitis
• Medical, social, and/or psychological problems precluding subject from study participation
• Stage 2, 3 or 4 chronic kidney disease or serum creatinine > 3 mg/dl or Glomerular Filtration Rate (GFR) less than 60 mL per minute per 1.73 m2 unless cleared by a nephrologist for participation
• Known allergy or sensitivity to chlorhexidine

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Arrow PICC with Chloragard Technology

Experimental group

Description:

Arrow Peripherally- Inserted Central Catheters with Chloragard Technology. The application of Chlorag+ard® Technology uses a proprietary process whereby chlorhexidine is chemically bonded to the intra- luminal catheter surfaces from tip to hub, and extra-luminal catheter body.

Treatment:

Device: Arrow PICC with Chloragard Technology