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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham Hyperbaric Oxygen Treatment | Sham Comparator |
| |
| Hyperbaric oxygen treatment (HBO) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyperbaric Oxygen treatment (HBO) | Procedure | HBO treatment will be given in a monoplace chamber and will start on first postoperative day (study day 1). The HBO group will be treated with 100% oxygen at 2.5 bar for 100 min with two 10 min airbrakes (without mask). HBO treatment will be given twice daily first three days (study day 1-3) and then once daily for up to three days (study day 4-6). The total number of treatments will be at least 6 and at most 9 treatments. Patients who have received at least three days HBO/placebo treatment and who have a clearly uncomplicated postoperative course will terminate HBO/placebo treatment on the day of discharge from hospital. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to complete healing of operative wounds | 7-365 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kerstin Brismar, Professor | Karolinska Institutet | Study Director |
| Jonas Malmstedt, MD | Karolinska Institutet | Principal Investigator |
| Folke G Lind, MD, PhD | Karolinska Institutet | Principal Investigator |
| Sergiu Catrina, MD, PhD | Karolinska Institutet | Principal Investigator |
| Joy Roy, MD, PhD | Karolinska Institutet | Principal Investigator |
| Nils Pettersson, MD, PhD | Karolinska Institutet | Principal Investigator |
| Bengt M Eriksson, MD | Hyperbaric Medicine, Karolinska Univ Hosp | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska University Hospital | Stockholm | 17176 | Sweden |
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| Sham HBO | Procedure | HBO sham treatment will start on first postoperative day (study day 1). HBO sham treatment will be given twice daily first three days (study day 1-3) and then once daily for up to three days (study day 4-6). The total number of treatments will be at least 6 and at most 9 treatments. Patients who have received at least three days HBO sham treatments and who have a clearly uncomplicated postoperative course will terminate HBO sham treatment on the day of discharge from hospital. For patient blinding purposes, the sham group will breathe air and will be given a brief compression to 1.5 bar at the beginning of each treatment after which the chamber is slowly decompressed to 1.1, 1.2 , 1.3, or 1.4 bar corresponding to 0.23 ,0.25, 0.27, and 0.29 bar inspired oxygen. Two 10 min "airbrakes" will also be included. |
|
| 30 days (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) |
| A combination of any wound infection and/or unhealed wounds at 30 days (combined endpoint). | 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 |
| 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) |
| HBO complications (confinement anxiety, barotrauma, oxygen convulsions) | During HBO treatment up to day 6 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D058729 | Peripheral Arterial Disease |
| D001157 | Arterial Occlusive Diseases |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
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