Prevention of Surgical Site Infections Using Gentamicin-containing Collagen Implants Following Inguinal Incision for Vascular Surgery: A Prospective Randomized Controlled Multicenter Trial

Abstract

endpoint, no intergroup differences were observed for the different SF-36 sum-and domain scores changes from baseline to five years except for the SF-36 role emotional domain score with a greater improvement in the nonrevascularization group (n¼116, p¼0.007). No intergroup differences were observed in VascuQoL total and domain scores changes (n¼116, n.s.) or treadmill walking distances (n¼91, n.s.). More patients had died in the revascularization group (n¼13 versus n¼7, n.s.) A revascularization strategy resulted in almost twice the cost compared to a non-invasive treatment approach (V10 915 vs V5 804) while there were no difference in the total QALYs per patient between the revascularization and the non-revascularization group. Conclusion: A liberal strategy of revascularization in patients with IC neither translated to any long-term HRQoL benefit nor to improved walking capacity at five years. Revascularization was equally not a cost-effective option from a payer/healthcare perspective. Future research should focus on a more precise targeting of IC subgroups that might still benefit from revascularization.