Peripheral Arterial Disease(PAD)NCT06631378
Transverse Versus Longitudinal Groin Incision in Vascular Surgery
A study testing Transverse groin incision and Longitudinal incision in people with Peripheral Arterial Disease(PAD) and Aneurysmal Disease, run by Kolding Sygehus at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Peripheral Arterial Disease(PAD), Aneurysmal Disease
- What is being tested?
- Transverse groin incision and Longitudinal incision
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 232 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Mar 2025to 1 Jul 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients undergoing vascular reconstruction with a groin incision
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Department of Vascular Surgery - Lillebaelt Hospital
Kolding, 6000
Christina P Madsen, MD, 0045 76360788, christina.pilgaard.madsen@rsyd.dk
Trine M M Jørgensen, MD PhD
About this study
Official title: 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.
- Being tested
- Transverse groin incision, Longitudinal incision
- Keywords
- groin wound complications, surgical site complications, surgical site complication, vascular surgery, incision type, incision
- Medical subject headings
- Peripheral Arterial Disease, Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transverse groin incisionProcedure or surgery
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 incisionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Transverse groin incision | Experimental | Not described Receives: Procedure: Transverse groin incision |
| Longitudinal groin incision | Active comparator | Not described Receives: Procedure: Longitudinal incision |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 35 days after the operation
Secondary outcomes (5)
Reoperation
Reoperation in the groin due to surgical site complications Reoperation due to the reconstruction Minor or major amputation
Measured: 35 days after the operation
Readmission
Is the patient readmitted due to either surgical site complications or for other reasons
Measured: 35 days
• Length of stay
The duration of the hospital stay after the operation.
Measured: 35 days
Mortality
Death and the cause of death.
Measured: 35 days
Healing of the groin
Evaluation of the groin to access if it has healed irrespective of the development of surgical site complications.
Measured: 35 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start1 Mar 2025
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial Disease(PAD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 232 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kolding Sygehus
- Sponsor type
- University, hospital or other
- Collaborators
- Region of Southern Denmark, University of Southern Denmark
- Responsible party
- Principal investigator, Christina Pilgaard Madsen, Kolding Sygehus
- Investigators
- Kim Trine Maria Mejnert Jørgensen, MD, PhD, Study director, Department of vascular surgery, Kolding Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06631378
- Sponsor's protocol ID
- KoldingSygehusKarkir
- Status last verified
- Mar 2025
- First submitted
- 27 Sep 2024
- Last updated
- 27 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No