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Trial record 2 of 3 for:    Inchingolo

Port Protectors for Prevention of CLABSIs in Respiratory Semi-intensive Care Unit

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ClinicalTrials.gov Identifier: NCT03486093
Recruitment Status : Completed
First Posted : April 3, 2018
Last Update Posted : April 3, 2018
Sponsor:
Information provided by (Responsible Party):
Riccardo Inchingolo, Catholic University of the Sacred Heart

Brief Summary:

Central Line-Associated BloodStream Infections (CLABSIs) are responsible for many deaths in the United States annually.

Several collaboratives have demonstrated the preventability of these infections.

Educational interventions decrease rates of CLABSIs. In addition to training, education, and surveillance, important prevention practices include the use of chlorhexidine skin antiseptics and maximal sterile barrier precautions at catheter insertion. Other maintenance practices include hand hygiene before handling catheters or catheter sites, chlorhexidine for skin antisepsis with dressing changes, and disinfecting catheter hubs or injection ports with an appropriate agent before accessing the catheter.

Antimicrobial catheter locks, including nonantibiotic antiseptic locks (such as alcohol or trisodium citrate), have also demonstrated some success in reducing CLABSIs. In particular, alcohol-impregnated port protectors and needleless neutral pressure connectors significantly reduced rates of CLABSIs.

Respiratory semi-intensive care units (RICUs) usually work as "step-up" units within acute care hospitals to manage patients with respiratory failure with non-invasive ventilation. These units may provide multidisciplinary rehabilitation and serve as a bridge to home-care programs or long-term care facilities. Some of these RICUs may work also as "step down" units for difficult to wean patients.

The investigators performed a single-centre prospective randomized clinical trial with the aim to assess the efficacy of educational interventions alone and combined with port protector as adjuvant tool on rate of CLABSIs. Moreover, the investigators evaluated the effects of previously mentioned interventions on rates of CVC colonizations and contaminated blood cultures.


Condition or disease Intervention/treatment Phase
Central Line-associated Bloodstream Infection (CLABSI) Device: Training and retraining to GAVECELT "bundle" recommendations plus port protector Behavioral: Training and retraining to GAVECELT "bundle" recommendations Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Patients have been randomized into two groups:

  1. patients with CVC managed by healthcare workers trained/retrained to GAVECELT recommendations.
  2. Patients with CVC managed by healthcare workers trained/retrained to GAVECELT recommendations with the aid of port protector devices.
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Randomized Clinical Trial on the Role of Port Protectors for the Management of Venous Central Line Catheter in Respiratory Semi-intensive Care Unit.
Actual Study Start Date : April 2013
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Arm Intervention/treatment
Experimental: CVC managed by healthcare workers
Patients with CVC managed by healthcare workers trained/retrained to GAVECELT recommendations.
Behavioral: Training and retraining to GAVECELT "bundle" recommendations
Physicians and nurses of RICU have been trained and retrained to GAVECELT "bundle" recommendations concerning the management of CVC. The bundle includes: hand hygiene and precautions for protection and safety, adequate insertion site, echo-guided placement of central venous line, use of clorexidine 2% for skin disinfection of insertion site chosen and subsequent continuous or discontinuous disinfection of exit site, use of suture-less devices, use of transparent semi-permeable dressing whenever applicable and immediate removal of catheter when no longer needed.

Experimental: CVC managed by healthcare workers plus port protector
Patients with CVC managed by healthcare workers trained/retrained to GAVECELT recommendations with the aid of port protector devices.
Device: Training and retraining to GAVECELT "bundle" recommendations plus port protector

Physicians and nurses of RICU have been trained and retrained to GAVECELT "bundle" recommendations concerning the management of CVC. The bundle includes: hand hygiene and precautions for protection and safety, adequate insertion site, echo-guided placement of central venous line, use of clorexidine 2% for skin disinfection of insertion site chosen and subsequent continuous or discontinuous disinfection of exit site, use of suture-less devices, use of transparent semi-permeable dressing whenever applicable and immediate removal of catheter when no longer needed.

After the first training meeting, the use of Curos® Disinfecting Port Protector for needleless valves port-protector has been introduced.

Other Name: Curos® Disinfecting Port Protector for needleless valves port-protector (CUROS, 70% isopropyl alcohol-impregnated, Ivera Medical, San Diego, California, US).




Primary Outcome Measures :
  1. Rate of CLABSIs. [ Time Frame: Through study completion, an average of 18 months. ]
    Efficacy of educational interventions alone and combined with port protector as adjuvant tool on rate of CLABSIs.


Secondary Outcome Measures :
  1. Rate of CVC colonizations [ Time Frame: Through study completion, an average of 18 months. ]
    Efficacy of educational interventions alone and combined with port protector as adjuvant tool on rate of CVC colonizations.

  2. Rate of contaminated blood cultures. [ Time Frame: Through study completion, an average of 18 months. ]
    Efficacy of educational interventions alone and combined with port protector as adjuvant tool on rate of contaminated blood cultures.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • CVC placed during hospitalization in RICU;
  • CVC already placed at admittance without signs of systemic inflammatory response syndrome (SIRS) during first 48h from admission to RICU;
  • CVC already placed at admittance without evidence of microbiologic contamination of blood cultures;
  • written informed consent.

Exclusion Criteria:

  • CVC placed during hospitalization in other Hospital;
  • CVC placed during hospitalization in other Unit with signs of systemic inflammatory response syndrome (SIRS) during first 48h from admission to RICU and / or evidence of microbiologic contamination of blood cultures.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03486093


Sponsors and Collaborators
Catholic University of the Sacred Heart
Investigators
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Principal Investigator: Riccardo Inchingolo, MD, PhD Fondazione Policlinico Universitario Gemelli, Catholic University of Sacred Heart
Study Director: Giuseppe M Corbo, MD, Prof. Fondazione Policlinico Universitario Gemelli, Catholic University of Sacred Heart

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Riccardo Inchingolo, Principal Investigator, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier: NCT03486093     History of Changes
Other Study ID Numbers: 5664/13
First Posted: April 3, 2018    Key Record Dates
Last Update Posted: April 3, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Riccardo Inchingolo, Catholic University of the Sacred Heart:
Venous central catheter
Central line-associated bloodstream infections
Port protector
Respiratory semi-Intensive Care Unit