NCT06631378

Transverse Versus Longitudinal Groin Incision in Vascular Surgery

The Incidence of Surgical Site Complications in Transverse Versus Longitudinal Groin Incision in Vascular Surgery: A Randomized Clinical Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 232 (estimated)
• Sponsor: Kolding Sygehus · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to examine whether incision type has an influence on the development of groin wound complications after operation in the groin in vascular surgery. The main questions it aims to answer are: Does a transverse incision in the groin lead to fewer surgical site complications than a longitudinal incision? Does a transverse incision lead to fewer readmissions, fewer reoperations, shorter length of hospital stay, and a lower amputation rate. Participants will undergo vascular surgery in the groin with either a transverse or longitudinal incision. The incision type will be selected randomly.

Conditions

• Peripheral Arterial Disease(PAD)
• Aneurysmal Disease

Interventions

Type	Name	Description
PROCEDURE	Transverse groin incision	The transverse incision is made parallel to the inguinal ligament either superiorly or inferiorly to the skin crease directly over the femoral artery. The subcutaneous tissue is dissected in the transverse direction till Scarpaes fascia after which the dissection is performed in the longitudinal direction along the line of the vessels. The lymphatic vessels are spared as much as possible. Any damaged lymph vessels are closed with surgical clips. Damages lymph nodes are either removed or the capsule is sutured to prevent lymph leakage. In case of difficulty with proper access to the femoral arteries, the incision can be extended either medially, laterally, or vertically.
PROCEDURE	Longitudinal incision	The longitudinal incision is made directly over the femoral artery from the inguinal ligament. The subcutaneous tissue is dissected along the line of the vessel sparing the lymphatic vessels as much as possible. Any damaged lymph vessels are closed with clips. Damages lymph nodes are either removed or the capsule is sutured to prevent lymph leakage.

Timeline

• Start date: 2025-03-01
• Primary completion: 2027-06-01
• Completion: 2027-07-01
• First posted: 2024-10-08
• Last updated: 2025-06-27

Locations

1 site across 1 country: Denmark