Ignite Creation Date:
2025-12-24 @ 11:17 PM
Ignite Modification Date:
2025-12-31 @ 3:23 AM
Study NCT ID:
NCT06766656
Status:
RECRUITING
Last Update Posted:
2025-11-28
First Post:
2025-01-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Transverse and Longitudinal Incisions for Venous Access Port Placement
Sponsor:
Jagiellonian University
Organization:
Study Overview
Official Title:
Comparison of Transverse and Longitudinal Incisions for Venous Access Port Placement
Status:
RECRUITING
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
port placement
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.
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: