Comparing skin incision directions for placing venous access ports
Comparison of Transverse and Longitudinal Incisions for Venous Access Port Placement
This study is testing whether the direction of the cut made during a procedure to place a venous access port affects pain, comfort, and complications for patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Jagiellonian University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Cracow) |
| Trial ID | NCT06766656 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the impact of incision direction (transverse vs. longitudinal) on pain, comfort, procedure time, and early complications in patients undergoing vascular port implantation. The procedure is performed under local anesthesia, where the internal jugular vein is cannulated, and a pocket for the port is created in the subclavicular area. Patients will be randomly assigned to receive either incision type, and outcomes will be assessed within the first 24 hours and after 7 days post-procedure. This is the first study of its kind to compare these two incision methods.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 who require central venous access for medical treatment.
Not a fit: Patients with impaired blood clotting, ongoing antiplatelet therapy, or a history of trauma or surgery on the shoulder girdles may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved patient comfort and reduced complications during venous access port placements.
How similar studies have performed: While this approach is novel, other studies have explored various techniques for venous access, but none have specifically compared incision directions in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Inclusion Criteria: Age \> 18 and \< 80 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 Septic state Agranulocytosis
Where this trial is running
Cracow
- Department of Intensive Interdisciplinary Care, Collegium Medicum, Jagiellonian University — Cracow, Poland (Recruiting)
Study contacts
- Study coordinator: Tomasz Skladzien, phd md
- Email: tomasz.skladzien@uj.edu.pl
- Phone: +48 12 400 1800
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.