Treatment OutcomePICC managemenNCT06944327
Reduction of Complications Associated With PICC Management
A study testing MANAGEMENT CARE and traditional care in people with Treatment Outcome 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 Outcome, Vascular Access, Vascular Access Device
- What is being tested?
- MANAGEMENT CARE and traditional care
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 460 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to 31 Dec 2027
- 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 PICC Management. Randomization in Care.
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).
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 (3M Tergaderm fully reinforced membrane (TSM) dressing), 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, 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 6-month follow-up period, 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.
- Conditions
- Treatment Outcome, Vascular Access, Vascular Access Device, Vascular Access Complication, Care Delivery, Nurse
- Being tested
- MANAGEMENT CARE, traditional care
- Keywords
- vascular, vascular access, catheter, central catheter, nurse, vascular access device, management, complication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MANAGEMENT CAREProcedure or 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 careOther
Traditional cure administration with sutureless device fixation every 7 days
| Study group | Role | What they receive |
|---|---|---|
| PIVC fixed with SecurAcath 7 DAYS | Placebo comparator | G1: PIVC fixed with SecurAcath, with care performed by heparinization with push-stop-push technique and positive pressure + fibrillin and semitransparent dressing change (Tergaderm 3M fully reinforced membrane dressing (TSM) every 7 days. Receives: Other: traditional care |
| PIVC fixed with SecurAcath 14 DAYS | Experimental | G2: PIVC fixed with SecurAcath, with care performed by heparinization with push-stop-push technique and positive pressure + fibrillin and dressing change dressing 7 semitransparent (fully reinforced membrane dressing (TSM) Tergaderm 3M every 14 days. Receives: Procedure: MANAGEMENT CARE |
| PIVC fixed with SecurAcath with Derma+ Flex® QS Skin Tissue Adhesive 7 days | Experimental | G3: PIVC fixed with SecurAcath PLUS Derma+ Flex® QS Skin Tissue Adhesive, with care performed by heparinization with push-stop-push technique and positive pressure + sealing solution + saline and semitransparent dressing change (Tergaderm 3M fully reinforced membrane dressing (TSM) every 7 days. Receives: Procedure: MANAGEMENT CARE |
| SecurAcath + Derma+ Flex® QS Skin Tissue Adhesive14 days | Experimental | PIVC fixed with SecurAcath PLUS Derma+ Flex® QS Skin Tissue Adhesive, with care performed by heparinization with push-stop-push technique and positive pressure + saline + sealing solution+ saline and semitransparent dressing change (Tergaderm 3M fully reinforced membrane dressing (TSM) every 14 days. Receives: Procedure: MANAGEMENT CARE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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 posted25 Apr 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Oct 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment OutcomeStudies 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 patients or legal guardians
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 460 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion Miguel Servet
- Sponsor type
- University, hospital or other
- Collaborators
- Complejo Hospitalario de Navarra
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06944327
- Sponsor's protocol ID
- Quality_PICC
- Other IDs
- Quality_PICC
- Acronym
- PICC managemen
- Status last verified
- Apr 2025
- First submitted
- 3 Apr 2025
- Last updated
- 25 Apr 2025
- 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 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Complications Associated With PICC Management. Randomization in Care.
- ClinicalTrials.gov ID
- NCT06944327
- Acronym / sponsor ID
- PICC managemen / Quality_PICC
- Conditions
- Treatment Outcome, Vascular Access, Vascular Access Device, Vascular Access Complication, Care Delivery, Nurse
- Keywords
- vascular, vascular access, catheter, central catheter, nurse, vascular access device, management, complication
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 460 participants (estimated)
- Lead sponsor
- Fundacion Miguel ServetUniversity, hospital or other
- Collaborators
- Complejo Hospitalario de Navarra
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 25 Apr 2025 (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 associated with extraluminal device care (thrombosis, phlebitis, accidental removal, obstruction).
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 (3M Tergaderm fully reinforced membrane (TSM) dressing), 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, 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 6-month follow-up period, 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
- 4
- 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 patients or legal guardians
| Arm | Type | Receives |
|---|---|---|
| PIVC fixed with SecurAcath 7 DAYS | Placebo comparator | Other: traditional careG1: PIVC fixed with SecurAcath, with care performed by heparinization with push-stop-push technique and positive pressure + fibrillin and semitransparent dressing change (Tergaderm 3M fully reinforced membrane dressing (TSM) every 7 days. |
| PIVC fixed with SecurAcath 14 DAYS | Experimental | Procedure: MANAGEMENT CAREG2: PIVC fixed with SecurAcath, with care performed by heparinization with push-stop-push technique and positive pressure + fibrillin and dressing change dressing 7 semitransparent (fully reinforced membrane dressing (TSM) Tergaderm 3M every 14 days. |
| PIVC fixed with SecurAcath with Derma+ Flex® QS Skin Tissue Adhesive 7 days | Experimental | Procedure: MANAGEMENT CAREG3: PIVC fixed with SecurAcath PLUS Derma+ Flex® QS Skin Tissue Adhesive, with care performed by heparinization with push-stop-push technique and positive pressure + sealing solution + saline and semitransparent dressing change (Tergaderm 3M fully reinforced membrane dressing (TSM) every 7 days. |
| SecurAcath + Derma+ Flex® QS Skin Tissue Adhesive14 days | Experimental | Procedure: MANAGEMENT CAREPIVC fixed with SecurAcath PLUS Derma+ Flex® QS Skin Tissue Adhesive, with care performed by heparinization with push-stop-push technique and positive pressure + saline + sealing solution+ saline and semitransparent dressing change (Tergaderm 3M fully reinforced membrane dressing (TSM) every 14 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
- accept participation in the study
- independent patient in the care and management of activities of daily living
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| MANAGEMENT CAREAdministration 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. | Procedure or surgery | PIVC fixed with SecurAcath 14 DAYS, PIVC fixed with SecurAcath with Derma+ Flex® QS Skin Tissue Adhesive 7 days, SecurAcath + Derma+ Flex® QS Skin Tissue Adhesive14 days |
| traditional careTraditional cure administration with sutureless device fixation every 7 days | Other | PIVC fixed with SecurAcath 7 DAYS |
Primary outcome
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).
Time frame: Measurement follow-up until removal or 6 and 12 months after catheter implantation.
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
1 secondary outcome
level of patient satisfaction related to various processes and frequencies of care
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 25 Apr 2025.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing MANAGEMENT CARE and traditional care in people with Treatment Outcome 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 25 Apr 2025. 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. Some participants in this study may receive a placebo. 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 M 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?
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). (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 25 Apr 2025.