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Transverse Versus Longitudinal Groin Incision in Vascular Surgery

NCT06631378 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 232

Last updated 2025-06-27

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Region of Southern Denmark

    collaborator OTHER

  • University of Southern Denmark

    collaborator OTHER

  • Kolding Sygehus

    lead OTHER

Principal Investigators

  • Kim Trine Maria Mejnert Jørgensen, MD, PhD · Department of vascular surgery, Kolding Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-01
Primary Completion
2027-06-01
Completion
2027-07-01

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06631378 on ClinicalTrials.gov