Study of Standard Maintenance Method of Intravenous Port and Post-operation Pain Analysis

September 22, 2023 updated by: Chang Gung Memorial Hospital
Investigators deconstructed the port that removed from patients and identified there were structural weakness, old blood clot and fibrin deposits. Investigators consider the problem may be exist in maintenance. After thoroughly examination the maintenance protocol, Investigators identified the problem and try to remodel the maintenance protocol. The Goal of this study was to testify the clinical value of standard maintenance protocol.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A secure and easily feasible vascular access is crucial for oncology patients because of the therapeutic need. Although intravenous port has been utilized for 3 decades, catheter-related complication still remain and had to deal with. According to investigators clinical experience, investigators summarized a standard algorithm as a recommendation for intravenous sport implantation. The complication before and after standard algorithm was 20 % and 3.5 %, respectively. However, catheter related infection and malfunction still could not be avoided. If patient was identified with these 2 complications, re-intervention is needed and cancer-related therapy has to be postpone. Investigators deconstructed the port that removed from patients and identified there were structural weakness, old blood clot and fibrin deposits. Investigators consider the problem may be exist in maintenance. After thoroughly examination the maintenance protocol, investigators identified the problem and try to remodel the maintenance protocol. The Goal of this study was to testify the clinical value of standard maintenance protocol.

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taoyuan, Taiwan, 333
        • Chang Gung Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Volunteer with new Port-A inserted

Exclusion Criteria:

  • No

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: experimental group
use Normal saline
Other: normal saline
experimental group use normal saline sealing tube
Active Comparator: comparator group
use Heparin
Other: normal saline+heparin
normal saline+heparin(Currently, Regular used in hospital)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Port- A Catheter complication
Time Frame: 1 year

In the case of catheter-related complications, a complete biochemical and blood test will be performed on the patient.

Will be tested for possible clotting factors, inflammatory index including CRP; procalcitonin; CBC / DC; PT / aPTT /Protein C/ protein S
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Investigators

  • Principal Investigator: Po-Jen Ko, MD, Chang Gung Memorial Hospital
  • Principal Investigator: Chien-Hung Chiu, MD, Chang Gung Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2016

Primary Completion (Actual)

July 31, 2019

Study Completion (Actual)

July 31, 2019

Study Registration Dates

First Submitted

October 24, 2018

First Submitted That Met QC Criteria

October 25, 2018

First Posted (Actual)

October 29, 2018

Study Record Updates

Last Update Posted (Actual)

September 25, 2023

Last Update Submitted That Met QC Criteria

September 22, 2023

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CGMH-IRB-104-9029B

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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