CLINICAL TRIAL
JOURNAL ARTICLE
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The role of radical surgery in the management of CEAP C5/6 and lipodermatosclerosis.

Phlebology 2016 December
Aim Analysis of the radical removing of the dermatosclerotic tissues and ulcer(s) with perforator veins dissection as well as local wound and standard compression treatment of CEAP C5/6 stage in a prospective comparative cohort study. Primary endpoint is to compare the results of the one-year follow-up regarding quality of life, vein clinical severity score, and ulcer healing process. Secondary endpoint is the precise presentation of the surgical technique. Tertiary endpoint is to demonstrate the photo-documented results of the postoperative wound treatment protocol. Method Clinical and statistical comparison of radical surgery versus solely wound care and compression in a cohort of 15 patients in each group (Groups 1, 2). In Group 1, radical removing of the dermatosclerotic pannicule and leg ulcer, perforator vein dissection, great saphenous vein, or small saphenous vein was performed. Quality of life , pain intensity, vein clinical severity score and patients' load capacity were compared. The tissue oxygen saturation changes were monitored via near infra-red spectroscopy. Results Both groups were statistically comparable. Wound healing in the operated group was 100% versus 60% in the second one, the difference was significant, p = 0.006. The quality of life: 45.33 versus 36.8, p < 0.001, intensity of leg restless and pain: 2.28 versus 5.3, p < 0.001, changes of vein clinical severity score: 5.27 versus 20.93, p < 0.001, changes of tO2sat : 19.00 versus 6.07 in the upper third of the leg p < 0.001, proved significantly better in group 1 compared to 2. Load capacity was significantly better in group 1 than 2 at the end of the study. The average wound healing time was 113 days in group 1. Conclusion The radical surgery provides significantly better results, considering quality of life, vein clinical severity score, load capacity than the conservative treatment in this study.

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