PhD-student, Vascular surgeon
Christina Pilgaard Madsen
Department of Vascular Surgery, Kolding Hospital
Projekt styring | ||
Projekt status | Open | |
Data indsamlingsdatoer | ||
Start | 01.02.2025 | |
Slut | 31.01.2027 | |
The objective of this trial is to examine if a transverse incision (TI) will reduce the number of postoperative surgical site complications in groin incisions in vascular surgery when compared to a longitudinal incision (LI). The trial is a single center superiority randomized clinical trial with two parallel groups with 1:1 randomization to either TI or LI in the groin in patients undergoing arterial reconstruction
The groin is a common incision site for vascular surgery. Among the vascular surgery patients comorbidities such as chronic obstructive pulmonary disease, coronary artery disease, diabetes, hypertension, and hyperlipidemia are common, and the patients are often elderly, and smokers all together making them at high risk for complications. Surgical site infection (SSI), dehiscence, lymph leak, lymphocele, and hematoma are common surgical site complications (SSCs) following groin incisions. We have conducted an audit of patients operated in the groin at out institution between January 2019 and December 2020, which showed that 18 % of the patients developed SSC. Infection of the groin occur in 9.3-15 % of patients after open surgery. SSIs have been shown to be the third most prevalent hospital associated infection in the European Union with a prevalence of 18.3 % highlighting the need for interventions. SSIs often requires further surgery and prolongs length of hospital stay and increase costs. The European Wound Management Association has written an extensive guideline with the current knowledge on the prevention and management of SSIs. Despite extensive knowledge in this area, SSIs remain a challenge especially in vascular surgery. A proposed method to reduce groin SSCs is to perform a transverse incision (TI) in the groin instead of the traditional longitudinal incision (LI) for femoral artery access. A recent systematic review and meta-analysis concluded that a TI is associated with reduced incidence of SSIs when compared with the LI. LI was associated with a RR of 2.93 (95 % CI 1.12 - 7.70, P=0.03) of groin wound infections. There are conflicting results with relation to lymph leak and lymphoceles. However, only two randomized studies studying the effects of the TI exist. Five studies found a higher incidence of wound infection in LI, though the effect was only significant in three studies. Kuyumdzheiv et al also found that a TI was associates with significantly fewer groin wound complications than the LI. There are several theories as to why TI is associated with fewer SSIs than LI. The TI follows Langer's lines of the skin and thereby causes less tension on the tissue. It avoids the skin crease in the groin, which is often moist and colonized with many bacteria thereby supposedly reducing the risk of infection. The LI is considered to offer better exposure of the femoral vessels. However, exposure of the great saphenous vein is more difficult with the TI, but it has been proposed that the TI can be prolonged, so sufficient access is possible.
Patients undergoing arterial reconstruction in the groin. The patients will be recruited at the department of vascular surgery.