RESUMEN
INTRODUCTION: Treatment of reflux has been shown to improve time to healing of Venous Leg Ulcers (VLU). Terminal Interruption of the Reflux Source (TIRS) treats reflux within the plexus of veins around an active VLU using foam sclerotherapy. The efficacy of TIRS in managing VLU has never been tested. METHODS: We performed a pragmatic, single centre, assessor-blinded, randomised controlled trial comparing endovenous ablation of the axial superficial veins (Axial Ablation-AA) vs TIRS. Patients of any age with VLU of any duration were eligible. RESULTS: 98 Participants were randomised to AA or TIRS. 39/55, 70.9% (95%CI; 57.1-82.37) healed their VLU in the AA group, while 29/39, 74.36% (95%CI; 57.87-86.96) healed their VLU in the TIRS group, P = 0.45.4 were lost to follow-up. Median time to ulcer healing was 84 days (95%CI; 74.67-93.33) in the axial ablation group and 84 days (95%CI; 73.02-94.98) in the TIRS group. Hazard Ratio for ulcer healing with AA vs TIRS was 0.96 (95%CI 0.59-1.56). There were no significant quality of life differences. CONCLUSION: The AAVTIRS trial did not show that axial ablation was superior to TIRS in the primary outcome of number of VLU healed in 6 months, or time to VLU healing. This trial is not powered to show non-inferiority. TIRS is a viable option for treatment of VLU. Further investigation is necessary before it can be recommended as an alternative to axial ablation.Trial registered at clinicaltrials.gov NCT04484168.
Asunto(s)
Escleroterapia , Úlcera Varicosa , Cicatrización de Heridas , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Técnicas de Ablación/efectos adversos , Procedimientos Endovasculares/efectos adversos , Calidad de Vida , Soluciones Esclerosantes/administración & dosificación , Soluciones Esclerosantes/efectos adversos , Escleroterapia/efectos adversos , Factores de Tiempo , Resultado del Tratamiento , Úlcera Varicosa/terapia , Úlcera Varicosa/cirugía , Úlcera Varicosa/fisiopatología , Insuficiencia Venosa/terapia , Insuficiencia Venosa/cirugía , Insuficiencia Venosa/fisiopatología , Insuficiencia Venosa/diagnóstico por imagenRESUMEN
OBJECTIVES: Venous leg ulcers (VLU) are prevalent and require a large investment of resources to manage. We investigated whether the introduction of a rapid access see-and-treat clinic for VLU patients affected rates of unplanned inpatient admissions with VLU. METHODS: The Hospital Inpatient Enquiry database was consulted for data on admission rates, length of stay, bed-days used, and costs, across a 4-year period; 2 years since the introduction of the clinic, and the 2 years prior as a control. RESULTS: Two hundred and eighteen patients admitted with VLU accounted for 2,529 inpatient bed-days, 4.5 (2-6) admissions per month, and a median hospital stay of 7 (4-13) days across the study period. Median admissions decreased from 6 (2.5-8.5) per month before, to 3.5 (2-5) after introduction of the clinic (p = 0.04). Bed-day usage fell from 62.5 (27-92.5), to 36.5 (21-44) days per month (p = 0.035). CONCLUSIONS: Admissions and bed-day usage for inpatient management of VLU fell after commencing a one-stop, rapid access clinic.