An interventional study of 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 Treatment (ProudMe), Vascular Access and Vascular Access Complication, sponsored by Fundacion Miguel Servet. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-03.
Sponsored by Fundacion Miguel Servet · Not applicable, Interventional, and Treatment
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
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
Fundacion Miguel Servet is the lead sponsor of 48 studies on the registry; 21 are open to participants now.
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be over 18 years of age
Exclusion Criteria:
patient over 18 years of age
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.
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
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
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, with care performed by heparinization with push-stop-push technique and positive pressure + fibrillin and semitransparent dressing change without chlorhexidine 15 days
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
Time frame: Measurement follow-up until removal or 6 and 12 months after catheter implantation
other complications
trombosis, MARSI, accidental removal
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
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
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
cost-benefit
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
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Fundacion Miguel Servet