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NCT Number: NCT06631378

Transverse Versus Longitudinal Groin Incision in Vascular Surgery

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.

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Key information

Conditions

Peripheral Arterial Disease(PAD) Aneurysmal Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Arterial Disease Peripheral Vascular Diseases Surgical Wound Vascular Diseases Wounds and Injuries

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Vascular Surgery - Lillebaelt Hospital

Kolding, 6000, Denmark

Location status: Recruiting

Location contact

Christina P Madsen, MD

CONTACT

[email protected]

0045 76360788

Christina Pilgaard Madsen, MD

PRINCIPAL_INVESTIGATOR

Trine M M Jørgensen, MD PhD

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients undergoing vascular reconstruction with a groin incision

Exclusion criteria

  • 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.

Treatment and study plan

Transverse groin incision

Procedure

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.

Longitudinal incision

Procedure

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.

Primary outcomes

  1. Incidence of surgical site complications

    Time frame: 35 days after the operation

    The surgical site complications are defined as follows:

    • Surgical site infection according to the Szilagy classification:
    • Dehiscence with separation of the wound edges and exposure of the underlying tissue.
    • Lymhocele defined as the presence of localized swelling in the groin and verified on ultrasound as an anechoic fluid collection.
    • Hematoma defined as the presence of localized swelling in the groin with discoloration and verified on ultrasound as an echoic fluid collection.

Secondary outcomes

  1. Reoperation

    Time frame: 35 days after the operation

    Reoperation in the groin due to surgical site complications Reoperation due to the reconstruction Minor or major amputation

  2. Readmission

    Time frame: 35 days

    Is the patient readmitted due to either surgical site complications or for other reasons

  3. • Length of stay

    Time frame: 35 days

    The duration of the hospital stay after the operation.

  4. Mortality

    Time frame: 35 days

    Death and the cause of death.

  5. Healing of the groin

    Time frame: 35 days

    Evaluation of the groin to access if it has healed irrespective of the development of surgical site complications.

Study contacts

Contact information is provided by the study sponsor or research team.

Christina P Madsen, Dr

CONTACT

[email protected]

+4576360788

Sponsors and collaborators

Lead sponsor

Kolding Sygehus

Other

Collaborators

  • Region of Southern Denmark
  • University of Southern Denmark

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Oct 8, 2024
Registry last updated
Jun 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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