Transverse Versus Longitudinal Groin Incision in Vascular Surgery

NCT06631378 | Recruiting

• 1 other identifier: KoldingSygehusKarkir
• Study Type: interventional
• Target: 232
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

groin wound complications; surgical site complications; surgical site complication; vascular surgery; incision type; incision

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Reoperation

  35 days after the operation

• Readmission

  35 days

• • Length of stay

  35 days

• Mortality

  35 days

• Healing of the groin

  35 days

Study Arms (2)

Transverse groin incision

EXPERIMENTAL

Procedure: Transverse groin incision

Longitudinal groin incision

ACTIVE COMPARATOR

Procedure: Longitudinal incision

Interventions

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.

Transverse groin incision

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.

Longitudinal groin incision

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing vascular reconstruction with a groin incision

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kolding Sygehus: lead
• Region of Southern Denmark: collaborator
• University of Southern Denmark: collaborator

Study Sites (1)

Department of Vascular Surgery - Lillebaelt Hospital

Kolding, 6000, Denmark

RECRUITING

MeSH Terms

Conditions

Peripheral Arterial Disease; Surgical Wound

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Wounds and Injuries

Study Officials

• Kim Trine Maria Mejnert Jørgensen, MD, PhD

  Department of vascular surgery, Kolding Hospital

  STUDY DIRECTOR

Central Study Contacts

Christina P Madsen, Dr

CONTACT

+4576360788; christina.pilgaard.madsen@rsyd.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD-student

Model Details: The trial is a single center superiority randomized clinical trial with two parallel groups with 1:1 randomization to either transverse or longitudinal incision in the groin in vascular surgery with arterial reconstruction.

Study Record Dates

• First Submitted: September 27, 2024
• First Posted: October 8, 2024
• Study Start: March 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: June 27, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)