A randomized clinical trial of the effects of saphenous and perforating veins radiofrequency ablation on venous ulcer healing (VUERT trial).
Autor: | Puggina, Juliana, Sincos, Igor Rafael, Campos Jr, Walter, Porta, Rina Maria P, dos Santos, Jorgete Barreto, De Luccia, Nelson, Puech-Leão, Pedro, Collares, Felipe Birchal, da Silva, Erasmo Simão |
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Předmět: |
DISEASE relapse prevention
SAPHENOUS vein WOUND healing RADIO frequency therapy TIME CATHETER ablation TREATMENT effectiveness RANDOMIZED controlled trials SEVERITY of illness index COMPARATIVE studies COMPRESSION therapy DESCRIPTIVE statistics LEG ulcers STATISTICAL sampling COMBINED modality therapy LONGITUDINAL method PATIENT safety EVALUATION |
Zdroj: | Phlebology; Apr2021, Vol. 36 Issue 3, p194-202, 9p |
Abstrakt: | Objectives: To investigate whether radiofrequency endovenous ablation (RFA) of saphenous and perforating veins increases venous leg ulcer (VLU) healing rates and prevents ulcer recurrence. Method: This prospective, open-label, randomized, controlled, single-center trial recruited 56 patients with VLU divided into: compression alone (CR, N = 29) and RFA plus compression (RF, N = 27). Primary endpoints were ulcer recurrence rate at 12 months; and ulcer healing rates at 6, 12, and 24 weeks. Secondary endpoints were ulcer healing velocity; and Venous Clinical Severity Score (VCSS). Results: Recurrence was lower in the RF group (p <.001), as well as mean VCSS after treatment (p =.001). There were no significant between-group differences in healing rates. Healing velocity was faster in the RF group (p = 0.049). In the RF group, 2 participants had type 1 endovenous heat-induced thrombosis (EHIT). Conclusions: RFA plus compression is an excellent treatment for VLU because of its safety, effectiveness, and impact on ulcer recurrence reduction and clinical outcome. Registration: Clinicaltrials.gov, NCT03293836, clinicaltrials.gov. [ABSTRACT FROM AUTHOR] |
Databáze: | Complementary Index |
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