Treatment (ProudMe)QualityPICC2NCT07802314
Reduction of Complications Associated With Extraluminal PICC Management.
A study testing 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 and 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 in people with Treatment (ProudMe) and Vascular Access, run by Fundacion Miguel Servet.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Treatment (ProudMe), Vascular Access, Vascular Access Complication
- What is being tested?
- 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 and 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
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2027to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- be over 18 years of age
- accept participation in the study
- independent patient in the care and management of activities of daily living
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Reduction of Complications Associated With Extraluminal PICC Management. QualityPICC2
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
Read the detailed description
Study variables and measurement instruments:
Sociodemographic and control variables: age and sex, reason for admission, clinical diagnosis, day of care. Device-related variables: Catheter type, brand, access type, caliber, number of lumens, infusion/pharmacological therapy, number of simultaneous therapies, days of access cannulation, frequency of care, antiseptic used in access manipulation, dressing and fixation system, other device care, direct and indirect costs. Dependent variables: Complications (infectious, mechanical, chemical, or thrombotic), reason for removal and accidental dislodgement, cost, patient satisfaction level.
Data collection:
The catheter will be inserted by the Intravenous Therapy Unit, which will provide the patient with information and sign a consent form prior to participation in the study. After the insertion process, the device placement representative will record the device characteristics and relevant aspects of the insertion, generating a 1-1 random assignment of the study participation group. This assignment will be done by giving the patient a code during the data entry process. This will allow for blinding of subsequent data collection and proper, anonymous follow-up of the case. Once insertion is complete, the device will be secured by applying Dermabond Mini glue (2-Octyl Cyanoacrylate), the SecurAcath system (a subcutaneous stabilization device that does not require changing while the catheter is in place), and a semi-transparent dressing (Tergaderm fully reinforced membrane (TSM) dressing wich clorhexidine), which will allow for monitoring the insertion site and randomizing care.
Once the study group has been assigned and the device has been placed, patient follow-up, including standardized device treatment at 7 days and the other goup with the same care but in a cadence of 15 days. this will be conducted by a trained professional dedicated exclusively to this care. Follow up data will be collected: date of treatment, treatment and elements used, and findings on the device or patient. The follow-up process will be blinded at all times by both the professional and the patient. After the established 12-month follow-up period, a analisys of the results and complications will be maked. also, a patient satisfaction questionnaire will be completed, and the coded data will be reported for assessment and interpretation by the research team. Likewise, an analysis of the economic costs involved in each care frequency will be performed, thanks to the collaboration of the center's financial management service, which will calculate the average direct and indirect costs resulting from each care frequency.
Data Analysis:
The collected data will be pre-coded by the research team, ensuring the anonymity of the data and all participants. The results will be recorded in the SPSS statistical software so that they can be analyzed and processed directly. For analysis and interpretation, support is provided by statistical experts within the research group, as well as by an institution that collaborates with some team members.
Ethical Aspects:
A request from the Research Ethics Committee has been made. Likewise, information for participants and family members is ensured through a written report that includes a comprehensive explanation of the project and participant rights. This report will be delivered after verbal communication and any questions are resolved. After verbal acceptance of participation in the process, a paper informed consent form is provided for the patient or legal guardian to sign
- Being tested
- 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, 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
- Keywords
- vascular access, vascular access device, complication, management, catheter, fixation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 daysProcedure or surgery
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
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 daysProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Measurement follow-up until removal or 6 and 12 months after catheter implantation
Secondary outcomes (2)
other complications
trombosis, MARSI, accidental removal
Measured: 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
level of patient satisfaction related to various processes and frequencies of care use of a liker-type scale (1-10) to determine the level of overall satisfaction with the care and handling of the device
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study start1 Jan 2027 (estimated)
- Primary completion20 Jan 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment (ProudMe)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion Miguel Servet
- Sponsor type
- University, hospital or other
- Collaborators
- Complejo Hospitalario de Navarra
- Responsible party
- Sponsor
- Investigators
- Marta Ferraz Torres, phd, Principal investigator, Hospital of Navarra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07802314
- Sponsor's protocol ID
- Miguel Servet
- Acronym
- QualityPICC2
- Status last verified
- Aug 2026
- First submitted
- 31 Aug 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Complications Associated With Extraluminal PICC Management. QualityPICC2
- ClinicalTrials.gov ID
- NCT07802314
- Acronym / sponsor ID
- QualityPICC2 / Miguel Servet
- Keywords
- vascular access, vascular access device, complication, management, catheter, fixation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Fundacion Miguel ServetUniversity, hospital or other
- Collaborators
- Complejo Hospitalario de Navarra
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 20 Jan 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 3 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Study variables and measurement instruments:
Sociodemographic and control variables: age and sex, reason for admission, clinical diagnosis, day of care. Device-related variables: Catheter type, brand, access type, caliber, number of lumens, infusion/pharmacological therapy, number of simultaneous therapies, days of access cannulation, frequency of care, antiseptic used in access manipulation, dressing and fixation system, other device care, direct and indirect costs. Dependent variables: Complications (infectious, mechanical, chemical, or thrombotic), reason for removal and accidental dislodgement, cost, patient satisfaction level.
Data collection:
The catheter will be inserted by the Intravenous Therapy Unit, which will provide the patient with information and sign a consent form prior to participation in the study. After the insertion process, the device placement representative will record the device characteristics and relevant aspects of the insertion, generating a 1-1 random assignment of the study participation group. This assignment will be done by giving the patient a code during the data entry process. This will allow for blinding of subsequent data collection and proper, anonymous follow-up of the case. Once insertion is complete, the device will be secured by applying Dermabond Mini glue (2-Octyl Cyanoacrylate), the SecurAcath system (a subcutaneous stabilization device that does not require changing while the catheter is in place), and a semi-transparent dressing (Tergaderm fully reinforced membrane (TSM) dressing wich clorhexidine), which will allow for monitoring the insertion site and randomizing care.
Once the study group has been assigned and the device has been placed, patient follow-up, including standardized device treatment at 7 days and the other goup with the same care but in a cadence of 15 days. this will be conducted by a trained professional dedicated exclusively to this care. Follow up data will be collected: date of treatment, treatment and elements used, and findings on the device or patient. The follow-up process will be blinded at all times by both the professional and the patient. After the established 12-month follow-up period, a analisys of the results and complications will be maked. also, a patient satisfaction questionnaire will be completed, and the coded data will be reported for assessment and interpretation by the research team. Likewise, an analysis of the economic costs involved in each care frequency will be performed, thanks to the collaboration of the center's financial management service, which will calculate the average direct and indirect costs resulting from each care frequency.
Data Analysis:
The collected data will be pre-coded by the research team, ensuring the anonymity of the data and all participants. The results will be recorded in the SPSS statistical software so that they can be analyzed and processed directly. For analysis and interpretation, support is provided by statistical experts within the research group, as well as by an institution that collaborates with some team members.
Ethical Aspects:
A request from the Research Ethics Committee has been made. Likewise, information for participants and family members is ensured through a written report that includes a comprehensive explanation of the project and participant rights. This report will be delivered after verbal communication and any questions are resolved. After verbal acceptance of participation in the process, a paper informed consent form is provided for the patient or legal guardian to sign
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| 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 | 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 daysG2: 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. |
| PIVC fixed with SecurAcath and chlorhexidine 15 DAYS G3 | Experimental | 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 daysG3: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- be over 18 years of age
Key exclusion criteria (5 listed)
- patient over 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 daysPIVC 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 or surgery | 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 daysPIVC 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 or surgery | PIVC fixed with SecurAcath and chlorhexidine 15 DAYS G3 |
Primary outcome
infections
Time frame: Measurement follow-up until removal or 6 and 12 months after catheter implantation
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
2 secondary outcomes
other complications
Time frame: 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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marta Ferraz Torres, phd principal investigator
Hospital of Navarra
Questions about this trial
What is this clinical trial studying?
A study testing 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 and 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 in people with Treatment (ProudMe) and Vascular Access, run by Fundacion Miguel Servet.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marta Ferraz Torres, Phd (+34648668085 ext. 52377, marta.ferraz.torres@navarra.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
infections (time frame: Measurement follow-up until removal or 6 and 12 months after catheter implantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.