Comparison of Transverse and Longitudinal Incisions for Venous Access Port Placement

NCT06766656 | Completed DMC

• 1 other identifier: 1072.6120.115.2024
• Study Type: interventional
• Target: 222
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Central Venous Access Devices; Implantable Venous Access Port

Keywords

Implantable venous access port (IVAP), Comfort, Complications; Central venous access devices

Outcome Measures

Primary Outcomes (1)

• Pain

  pain monitored on the NRS scale at 1, 2, 6, 12, 24 hours after the procedure

  1 day

Secondary Outcomes (1)

• Discomfort

  7 days

Study Arms (2)

transversely incision

ACTIVE COMPARATOR

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

longitudinally incision

ACTIVE COMPARATOR

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

Interventions

Incision PROCEDURE

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

longitudinally incision; transversely incision

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jagiellonian University: lead

Study Sites (1)

Department of Intensive Interdisciplinary Care, Collegium Medicum, Jagiellonian University

Krakow, Poland

Location

Related Publications (2)

• 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.

  PMID: 36687176 RESULT

• 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.

  PMID: 21922348 RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer

Model Details: 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.

Study Record Dates

• First Submitted: January 4, 2025
• First Posted: January 9, 2025
• Study Start: February 1, 2025
• Primary Completion: September 30, 2025
• Study Completion: December 31, 2025
• Last Updated: March 31, 2026

Record last verified: 2025-01

Locations

PL (1)