NCT01002209WithdrawnPhase 2
Postoperative Hyperbaric Oxygen Treatments to Reduce Complications in Diabetic Patients Undergoing Vascular Surgery (HODiVA) - A Double Blind, Randomized Controlled Study
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 2
- Status
- Withdrawn
- Sponsor
- Karolinska Institutet
- Locations
- 1
- Primary Endpoint
- Time to complete healing of operative wounds
Study Overview
Brief Summary
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Sham Hyperbaric Oxygen Treatment
Sham Comparator
Intervention: Sham HBO (Procedure)
Hyperbaric oxygen treatment (HBO)
Experimental
Intervention: Hyperbaric Oxygen treatment (HBO) (Procedure)
Outcomes
Primary Outcomes
Time to complete healing of operative wounds
Time Frame: 7-365 days
Secondary Outcomes
- 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)
Investigators
Study Sites (1)
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