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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
232
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.
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.
Department of Vascular Surgery - Lillebaelt Hospital
Kolding, Denmark
RECRUITINGIncidence 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.
Time frame: 35 days after the operation
Reoperation
Reoperation in the groin due to surgical site complications Reoperation due to the reconstruction Minor or major amputation
Time frame: 35 days after the operation
Readmission
Is the patient readmitted due to either surgical site complications or for other reasons
Time frame: 35 days
• Length of stay
The duration of the hospital stay after the operation.
Time frame: 35 days
Mortality
Death and the cause of death.
Time frame: 35 days
Healing of the groin
Evaluation of the groin to access if it has healed irrespective of the development of surgical site complications.
Time frame: 35 days
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