Aneurysmal Disease, Peripheral Arterial Disease(PAD)
Conditions
Keywords
groin wound complications, surgical site complications, surgical site complication, vascular surgery, incision type, incision
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.
Interventions
PROCEDURETransverse 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.
PROCEDURELongitudinal 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
Region of Southern Denmark
University of Southern Denmark
Kolding Sygehus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of surgical site complications | 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
| Measure | Time frame | Description |
|---|---|---|
| Reoperation | 35 days after the operation | Reoperation in the groin due to surgical site complications Reoperation due to the reconstruction Minor or major amputation |
| Readmission | 35 days | Is the patient readmitted due to either surgical site complications or for other reasons |
| • Length of stay | 35 days | The duration of the hospital stay after the operation. |
| Mortality | 35 days | Death and the cause of death. |
| Healing of the groin | 35 days | Evaluation of the groin to access if it has healed irrespective of the development of surgical site complications. |
Countries
Denmark
Contacts
Primary ContactChristina P Madsen, Dr
Outcome results
None listed