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

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.

Study Overview

• Status: Recruiting
• Conditions: Peripheral Arterial Disease(PAD); Aneurysmal Disease
• Intervention / Treatment: Procedure: Transverse groin incision; Procedure: Longitudinal incision

• Study Type: Interventional
• Enrollment (Estimated): 232
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christina P Madsen, Dr; Phone Number: +4576360788; Email: christina.pilgaard.madsen@rsyd.dk

Study Locations

• Denmark
  • Kolding, Denmark, 6000
    • Recruiting
    • Department of Vascular Surgery - Lillebaelt Hospital
    • Contact: Christina P Madsen, MD; Phone Number: 0045 76360788; Email: christina.pilgaard.madsen@rsyd.dk
    • Contact: Trine M M Jørgensen, MD PhD
    • Principal Investigator: Christina Pilgaard Madsen, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Transverse groin incision	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.
Active Comparator: Longitudinal groin incision	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of surgical site complications	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.	35 days after the operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reoperation	Reoperation in the groin due to surgical site complications Reoperation due to the reconstruction Minor or major amputation	35 days after the operation
Readmission	Is the patient readmitted due to either surgical site complications or for other reasons	35 days
• Length of stay	The duration of the hospital stay after the operation.	35 days
Mortality	Death and the cause of death.	35 days
Healing of the groin	Evaluation of the groin to access if it has healed irrespective of the development of surgical site complications.	35 days

Collaborators and Investigators

• Sponsor: Kolding Sygehus
• Collaborators: University of Southern Denmark; Region of Southern Denmark
• Investigators: Study Director: Kim Trine Maria Mejnert Jørgensen, MD, PhD, Department of vascular surgery, Kolding Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: September 27, 2024
• First Submitted That Met QC Criteria: October 7, 2024
• First Posted (Actual): October 8, 2024

Study Record Updates

• Last Update Posted (Actual): June 27, 2025
• Last Update Submitted That Met QC Criteria: June 24, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: vascular surgery; incision; groin wound complications; surgical site complications; surgical site complication; incision type
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Wounds and Injuries; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Surgical Wound; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: KoldingSygehusKarkir

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No