Postoperative complications after vascular surgery in the leg. This includes wound infections, wound dehiscience and necrosis MedDRA version: 9.1 Level: LLT Classification code 10057480 Term: Hyperbaric oxygen therapy
Conditions
Interventions
Trade Name: Medicinsk Oxygen AGA 100 %, Medicinsk gas, kryogen
Product Name: Medicinsk Oxygen
Pharmaceutical Form: Inhalation gas
INN or Proposed INN: Oxygen
CAS Number: 7782447
Other descriptive name
Sponsors
Karolinska Universitetssjukhuset
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients are eligible for inclusion if the following criteria are fulfilled 1. Informed consent obtained 2. Scheduled for lower extremity open vascular surgery 3. Diabetes treated with insulin or oral antidiabetic medicine 4. 18 years or older Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients having any of the following at randomization will not be included in the study 1. Contraindications to HBO therapy 2. Pregnancy 3. Patients already in HBO treatment 4. Creatinine > 250 mmol/L 5. NYHA class IV heart failure or severe cardiopulmonary disease with desaturation judged to be incompatible with safe HBO/ placebo therapy in a monoplace chamber 6. 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. 7. Simultaneous or previous (within 30 days prior to study entry) participation in a clinical study using experimental drugs or devices. 8. Mental condition making the subject unable to understand the concepts and risk of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate whether postoperative HBO vs placebo will lead to a shorter time to healing of operative wounds.;Secondary Objective: To evaluate whether postoperative HBO vs placebo will: a) lead to an improvement in the proportion of healed operative wounds assed at 30 days. b) lead to reduction in postoperative wound infections in patients with diabetes undergoing infrainguinal bypass surgery. c) lead to a decrease in wound infection severity. d) lead to an increased peripheral tissue oxygenation measured with Transcutaneous PO2 e) lead to an improvement in quality of life measured with SF-36. f) lead to an improvement in amputation-free survival up to 1 year. g) lead to a reduction of total hospital stay. ;Primary end point(s): 1) The primary outcome is healing of all operative wounds defined as complete epithelialisation and no need for wound dressings. This will be asseed by comparing time to complete healing between treatment groups. | — |
Countries
Sweden
Outcome results
None listed