Actively Recruiting
The Incidence of Surgical Site Complications in Transverse Versus Longitudinal Groin Incision in Vascular Surgery: A Randomized Clinical Trial
Led by Kolding Sygehus · Updated on 2025-06-27
232
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
Sponsors
K
Kolding Sygehus
Lead Sponsor
R
Region of Southern Denmark
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to determine whether the type of groin incision used in vascular surgery affects the development of surgical site complications. The study focuses on patients undergoing vascular reconstruction in the groin area, comparing transverse incisions to longitudinal incisions. The main questions include whether transverse incisions result in fewer complications, readmissions, reoperations, shorter hospital stays, and lower amputation rates. Participants are randomly assigned to have either a transverse or longitudinal groin incision during their vascular surgery. The transverse incision is made parallel to the inguinal ligament with careful dissection to preserve lymphatic vessels, while the longitudinal incision is made directly over the femoral artery with similar attention to lymphatic preservation. The surgical approach may be adjusted if necessary for adequate artery access. During the study, researchers will monitor surgical site complications, reoperations, readmissions, length of hospital stay, mortality, and groin healing over a 35-day period after the operation. Participants will be followed closely during this time to assess outcomes related to their incision type. The study does not involve masking, and the allocation to incision type is randomized to ensure objective comparison.
CONDITIONS
Brief Title
Transverse Versus Longitudinal Groin Incision in Vascular Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients undergoing vascular reconstruction with a groin incision
You will not qualify if you...
- Patients previously operated with a groin incision
- Patients undergoing operation due to trauma, bleeding, or pseudoaneurysm
- Patients operated within the first 24 hours of admission
- If it prior to the operation is deemed necessary with a muscleplasty
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Day of surgery
Participants undergo either a transverse or longitudinal groin incision as part of vascular surgery, followed by immediate post-operative care to monitor surgical site complications.
1 surgery visit (in-person)
Duration - 35 days after the operation
Participants are monitored for surgical site complications, healing, and other outcomes after the operation.
Approximately 2 to 3 visits during the 35 days
Trial Site Locations
Total: 1 location
1
Department of Vascular Surgery - Lillebaelt Hospital
Kolding, Denmark, 6000
Actively Recruiting
Research Team
C
Christina P Madsen, Dr
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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