Comparison of Transverse and Longitudinal Incisions for Venous Access Port Placement (port placement)

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.

Study Overview

• Status: Completed
• Conditions: Central Venous Access Devices; Implantable Venous Access Port
• Intervention / Treatment: Procedure: Incision

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 222
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Inclusion Criteria:

Age > 18 and < 85 years Informed consent Need for central venous access port implementation under local anesthesia

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 Chronic opioid use Septic state Agranulocytosis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: transversely incision; The "pocket" for the vascular port is made through a small incision in the skin in the subclavicular area. The skin incision will be made transversely	Procedure: Incision; 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
Active Comparator: longitudinally incision; The "pocket" for the vascular port is made through a small incision in the skin in the subclavicular area. The skin incision will be made longitudinally,	Procedure: Incision; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain	pain monitored on the NRS scale at 1, 2, 6, 12, 24 hours after the procedure	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Discomfort	discomfort associated with the presence of the vascular port on a scale of 0-5	7 days

Collaborators and Investigators

• Sponsor: Jagiellonian University

Publications and helpful links

General Publications

• Erdemir A, Rasa HK. Impact of central venous port implantation method and access choice on outcomes. World J Clin Cases. 2023 Jan 6;11(1):116-126. doi: 10.12998/wjcc.v11.i1.116.
• Walser EM. Venous access ports: indications, implantation technique, follow-up, and complications. Cardiovasc Intervent Radiol. 2012 Aug;35(4):751-64. doi: 10.1007/s00270-011-0271-2. Epub 2011 Sep 16.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2025
• Primary Completion (Actual): September 30, 2025
• Study Completion (Actual): December 31, 2025

Study Registration Dates

• First Submitted: January 4, 2025
• First Submitted That Met QC Criteria: January 4, 2025
• First Posted (Actual): January 9, 2025

Study Record Updates

• Last Update Posted (Actual): March 31, 2026
• Last Update Submitted That Met QC Criteria: March 30, 2026
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Implantable venous access port (IVAP), Comfort, Complications; Central venous access devices
• Other Study ID Numbers: 1072.6120.115.2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No