Postoperative Hyperbaric Oxygen Treatments to Reduce Complications in Diabetic Patients Undergoing Vascular Surgery

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

This trial aims to evaluate if hyperbaric oxygen treatment (HBO) given postoperatively is effective in reducing healing time and wound complications after lower extremity bypass surgery in patients with diabetes.

Hypothesis: Postoperative HBO treatment is effective in reducing complications in patients with diabetes undergoing peripheral vascular surgery

Inclusion Criteria:

• Patients are eligible for inclusion if the following criteria are fulfilled
• Informed consent obtained
• Scheduled for lower extremity open vascular surgery
• Diabetes treated with insulin or oral antidiabetic medicine
• Age ≥ 18 years

Exclusion Criteria:

• Contraindications to HBO therapy
• Pregnancy (women of childbearing potential will undergo pregnancy test before inclusion)
• Patients already in HBO treatment
• Vascular reoperation
• Creatinine > 250 mmol/L
• NYHA class IV heart failure or severe cardiopulmonary disease with desaturation judged to be incompatible with safe HBO/ placebo therapy in a monoplace chamber
• Clinically significant chronic obstructive pulmonary disease.
• Acute sepsis.
• Malignancy or other serious medical condition where it is likely that the patient will significantly deteriorate or not survive within the two years of follow up.
• Simultaneous or previous (within 30 days prior to study entry participation in a clinical study using experimental drugs or devices.
• Mental condition making the subject unable to understand the concepts and risk of the study