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Reduction of Complications Associated With PICC Management

ConditionsTreatment OutcomeVascular AccessVascular Access DeviceVascular Access ComplicationCare DeliveryNurseNurse Based Care Management
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFundacion Miguel Servet

About this trial

The present study aims to analyze different care routes of the peripheral access central venous catheter to assess which alternative allows a moderate reduction in the level of complications associated with prolonged care frequency, due to the reduction of device manipulation.

A high level of patient satisfaction is detected due to the controlled follow-up of the device care, as well as a decrease in the need for transfer to a center for follow-up.

Objective: Identify the type of care frequency for PIVCs most beneficial for the reduction of complications associated with extraluminal device care (thrombosis, phlebitis, accidental removal, obstruction).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

be over 18 years of age

accept participation in the study

independent patient in the care and management of activities of daily living

Disqualifiers

patient over 18 years of age

patient with functional or cognitive limitation

patient with mild, moderate or high level of dependence

patient does not accept to perform the study

Trial design

Design model

Parallel

Treatments tested in this trial

  • MANAGEMENT CARE

    Procedure/Surgery

    Administration of the sealing element after canalization and initial treatment of the device, prior to fixation with a suture system and a 7-day vs. 14-day cadence test.

  • traditional care

    Other intervention

    Traditional cure administration with sutureless device fixation every 7 days

Treatment groups

460 Participants
are divided into 4 treatment groups
Group A: PIVC fixed with SecurAcath 7 DAYSPlacebo comparator 1 intervention
Group B: PIVC fixed with SecurAcath 14 DAYSExperimental treatment 1 intervention
Group C: PIVC fixed with SecurAcath with Derma+ Flex® QS Skin Tissue Adhesive 7 daysExperimental treatment 1 intervention
Group D: SecurAcath + Derma+ Flex® QS Skin Tissue Adhesive14 daysExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Identify the type of frequency of care for PIVCs most beneficial for the reduction of complications associated with extraluminal device care (LESS thrombosis, phlebitis, accidental removal, obstruction).

Reduction of complications such as thrombosis, phlebitis, accidental withdrawals, obstruction. measurement of the various complications according to: number of associated complications per device according to intervention group

Time frame
Measurement follow-up until removal or 6 and 12 months after catheter implantation.

Secondary outcomes

1

level of patient satisfaction related to various processes and frequencies of care

use of a liker-type scale to determine the level of overall satisfaction with the care and handling of the device

Time frame
day 1, day 7, day 14, at 6 months after placement and start of the study of the device and at 12 months after the device is removed.

Other outcomes

1

Recognize the cost-effectiveness of each of the randomization groups included in the study.

Measurement of direct and indirect costs of device care by study group, taking into account whether there are complications and the costs associated with them.

Time frame
day 1, day 7, day 14, at 6 months after placement and start of the study of the device and at 12 months after the device is removed. at 6 months after placement and start of the study of the device and at 12 months after the device is removed

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fundacion Miguel Servet

Lead sponsor

Complejo Hospitalario de Navarra

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: