Postoperative Hyperbaric Oxygen Treatments to Reduce Complications in Diabetic Patients Undergoing Vascular Surgery (HODiVA) - A Double Blind, Randomized Controlled Study

简要总结

主要结局

次要结局

• Tissue perfusion and oxygenation on dorsum of foot on operated extremity as assessed by Transcutaneous oximetry during normobaric air breathing and after 6 min normobaric 100% oxygen challenge(day 3-5, 7 and 14, 28, 365 (plus minus 3 days))
• The severity of wound infection defined as by ASEPSIS score: 0-10= satisfactory healing 11-20= disturbed healing 21-30= minor wound infection 31-40= moderate wound infection >40= severe wound infection.(highest score up to 30 days (plus minus 3 days))
• SF-36 score(7, 14, 28, 365 days (plus minus 3 days))
• Major amputation or death. This will be assessed as "amputation-free survival". A major amputation is defined as any ipsilateral amputation through or above the ankle.(0-365 days)
• Number of wound infections at 7 days assessed by ASEPSIS score. A score over 20 will be considered as a wound infection.(7 days (plus minus 3 days))
• Number of wound infections at 30 days assessed by ASEPSIS score. A score over 20 will be considered as a wound infection.(30 days (plus minus 3 days))
• A combination of any wound infection and/or unhealed wounds at 30 days (combined endpoint).(30 days (plus minus 3 days))
• HBO complications (confinement anxiety, barotrauma, oxygen convulsions)(During HBO treatment up to day 6)