Reduction of Complications Associated With Extraluminal PICC Management.

NCT07802314 | Not Yet Recruiting

• 1 other identifier: Miguel Servet
• Study Type: interventional
• Target: 240
• Locations: 0 countries
• Sites: N/A

Brief Summary

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 (first infection and second MARSI) associated with extraluminal device care with clorhexidine fixation

Conditions

Treatment (ProudMe); Vascular Access; Vascular Access Complication; Nurse

Keywords

vascular access; vascular access device; complication; management; catheter; fixation

Outcome Measures

Primary Outcomes (1)

• infections

  Identify the type of frequency of care for PIVCs most beneficial for the reduction of complications associated with extraluminal device care (less phlebitis, and bacteriemias) Reduction also of complications such as thrombosis, accidental withdrawals, obstruction. measurement of the various complications according to: number of associated complications per device according to intervention group

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

Secondary Outcomes (2)

• other complications

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

• satisfaction

  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)

• cost-benefit

  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

Study Arms (3)

control

NO INTERVENTION

G1: PIVC fixed with SecurAcath, with care performed by heparinization with push-stop-push technique and positive pressure + fibrillin and semitransparent dressing change (Tergaderm fully reinforced membrane dressing (TSM) with clorhexidine every 7 days.

PIVC fixed with SecurAcath 15 DAYS G2

EXPERIMENTAL

G2: PIVC fixed with SecurAcath, with care performed by heparinization with push-stop-push technique and positive pressure + fibrillin and semitransparent dressing change (Tergaderm fully reinforced membrane dressing (TSM) with clorhexidine every 15 days.

Procedure: G2:PIVC fixed with SecurAcath, with care performed by heparinization with push-stop-push technique and positive pressure + fibrillin and semitransparent dressing change with chlorhexidine 15 days

PIVC fixed with SecurAcath and chlorhexidine 15 DAYS G3

EXPERIMENTAL

G3: PIVC fixed with SecurAcath, with care performed by heparinization with push-stop-push technique and positive pressure + fibrillin and semitransparent dressing change (Tergaderm fully reinforced membrane dressing (TSM) without clorhexidine every 15 days.

Procedure: G3: PIVC fixed with SecurAcath, with care performed by heparinization with push-stop-push technique and positive pressure + fibrillin and semitransparent dressing change without chlorhexidine 15 days

Interventions

G2:PIVC fixed with SecurAcath, with care performed by heparinization with push-stop-push technique and positive pressure + fibrillin and semitransparent dressing change with chlorhexidine 15 days PROCEDURE

PIVC fixed with SecurAcath, with care performed by heparinization with push-stop-push technique and positive pressure + fibrillin and semitransparent dressing change with chlorhexidine 15 days

PIVC fixed with SecurAcath 15 DAYS G2

G3: PIVC fixed with SecurAcath, with care performed by heparinization with push-stop-push technique and positive pressure + fibrillin and semitransparent dressing change without chlorhexidine 15 days PROCEDURE

PIVC fixed with SecurAcath, with care performed by heparinization with push-stop-push technique and positive pressure + fibrillin and semitransparent dressing change without chlorhexidine 15 days

PIVC fixed with SecurAcath and chlorhexidine 15 DAYS G3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• be over 18 years of age
• accept participation in the study
• independent patient in the care and management of activities of daily living

You may not qualify if:

• 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
• patient with device withdrawal prior to 14 days of duration

Sponsors & Collaborators

• Fundacion Miguel Servet: lead
• Complejo Hospitalario de Navarra: collaborator

MeSH Terms

Interventions

Fibrillins; Chlorhexidine

Intervention Hierarchy (Ancestors)

Glycoproteins; Glycoconjugates; Carbohydrates; Proteins; Amino Acids, Peptides, and Proteins; Extracellular Matrix Proteins; Scleroproteins; Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Marta Ferraz Torres, phd

  Hospital of Navarra

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marta Ferraz Torres, Phd

CONTACT

+34648668085; marta.ferraz.torres@navarra.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized prospective longitudinal design, by means of a representative sample selection of the study population, in a simple randomized fashion. The study will be conducted and piloted at the Hospital Universitario de Navarra, in the Intravenous Therapy Unit (ITU). A certain number of patients who meet the inclusion criteria (representative sample of the population to be studied) will be registered and analyzed during the same period (6 months) to determine and record the study variables and outcome data. In this case, the inclusion criteria for taking part in the study will be all patients over 18 years of age, with a level of independence for optimal care and attended in the ICU for the insertion of a long-term PIVC device who voluntarily accept to participate in the study. As selection criteria, all cases of dependent, bedridden and hemodynamically unstable patients will be considered as exclusion criteria, as well as all users who, after informing the p

Study Record Dates

• First Submitted: August 31, 2026
• First Posted: September 3, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): January 20, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: September 3, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share