Postoperative Hyperbaric Oxygen treatments to reduce complications in Diabetic patients undergoing Vascular Surgery (HODIVA) - A double blind, randomized controlled study - HODIVA

Conditions: Postoperative complications after vascular surgery in the leg. This includes wound infections, wound dehiscience and necrosis
MedDRA version: 9.1Level: LLTClassification code 10057480Term: Hyperbaric oxygen therapy

Registration Number: EUCTR2008-003731-20-SE

Lead Sponsor: Karolinska Universitetssjukhuset

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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:<br>a) lead to an improvement in the proportion of healed operative wounds assed at 30 days.<br>b) lead to reduction in postoperative wound infections in patients with diabetes undergoing infrainguinal bypass surgery.<br>c) lead to a decrease in wound infection severity.<br>d) lead to an increased peripheral tissue oxygenation measured with Transcutaneous PO2<br>e) lead to an improvement in quality of life measured with SF-36.<br>f) lead to an improvement in amputation-free survival up to 1 year.<br>g) lead to a reduction of total hospital stay.<br>;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.

Secondary Outcome Measures