Comparison of Transverse and Longitudinal Incisions for Venous Access Port Placement

Last updated: April 2, 2025
Sponsor: Jagiellonian University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Injection Port

Treatment

Incision

Clinical Study ID

NCT06766656
1072.6120.115.2024
  • Ages 18-80
  • All Genders

Study Summary

The aim of the study is to assess whether the direction of skin incision affects pain within the first 24 hours, patient comfort 7 days after the procedure, procedure time, and the occurrence of early complications related to vascular port implantation.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Inclusion Criteria:

Age > 18 and < 80 years Informed consent Need for central venous access port implementation under local anesthesia

Exclusion

Exclusion Criteria:

Impaired blood clotting Ongoing antiplatelet drugs therapy, except acetylsalicylic acid Trauma or surgical past history on both shoulder girdles Known central venous thrombosis (subclavian vein, upper vena cava) Known pneumothorax Septic state Agranulocytosis

Study Design

Total Participants: 200
Treatment Group(s): 1
Primary Treatment: Incision
Phase:
Study Start date:
February 01, 2025
Estimated Completion Date:
January 31, 2026

Study Description

The vascular port implantation procedure is used in patients who require long-term access to veins, e.g. during chemotherapy, long-term drug administration or blood collection. This procedure is performed under local anesthesia, by cannulating the internal jugular vein - left or right and making an incision to place the port on the chest wall (so-called "pocket") in the subclavicular area on the side of the cannulated vein.

Vessel cannulation is performed percutaneously using an ultrasound machine and fluoroscopy. The "pocket" for the vascular port is made through a small incision in the skin in the subclavicular area. The skin incision can be made transversely or longitudinally, depending on the preferences of the physician performing the procedure. In both cases, this does not affect the further course of the procedure. Both methods of creating a vascular "pocket" are commonly used. The procedures are performed as part of one-day stays, and after the procedure, patients are discharged home.

To the best of our knowledge, this is the first study that will compare the direction of the skin incision. In our study, we wanted to compare pain in the first 24 hours, patient comfort after 7 days of the procedure, procedure time, occurrence of early complications related to vascular port implantation. Patients undergoing the vascular port implantation procedure will be divided into two groups, one will have a transverse incision, and the other a longitudinal incision in order to place the port in the subcutaneous tissue. Patients will receive a questionnaire to fill out (in the appendix to the application) and will have their pain monitored on the NRS scale at 1, 2, 6, 12, 24 hours after the procedure. Additionally, on the 7th day after the procedure, I will be asked to assess any discomfort associated with the presence of the vascular port on a scale of 0-5. Data will be collected by phone. Additionally, we will measure the procedure time and occurrence of any complications related to port implantation.

Connect with a study center

  • 1Department of Intensive Interdisciplinary Care, Collegium Medicum, Jagiellonian University

    Cracow,
    Poland

    Site Not Available

  • Department of Intensive Interdisciplinary Care, Collegium Medicum, Jagiellonian University

    Cracow,
    Poland

    Active - Recruiting

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