NCT01002209|WithdrawnPhase 2/3
Study Stopped
Changes in the organisation
Postoperative Hyperbaric Oxygen Treatments to Reduce Complications in Diabetic Patients Undergoing Vascular Surgery
HODiVA
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Sponsor study identifier
interventional
0
1 country
1
Study Start
October 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
October 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 26, 2009
Actual (reported)October 27, 2009
Actual (reported)October 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Time to complete healing of operative wounds
7-365 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)
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.
Karolinska University Hospital
Stockholm, 17176, Sweden
Kerstin Brismar, Professor
Karolinska Institutet
Jonas Malmstedt, MD
Karolinska Institutet
Folke G Lind, MD, PhD
Karolinska Institutet
Sergiu Catrina, MD, PhD
Karolinska Institutet
0 participants (actual enrollment reported by the registry).
First Submitted
October 26, 2009
First Posted
October 27, 2009
Study Start
October 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Allogeneic Mesenchymal Stromal Cells for Angiogenesis and Neovascularization in No-option Ischemic Limbs
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)
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.
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Joy Roy, MD, PhD
Karolinska Institutet
Nils Pettersson, MD, PhD
Karolinska Institutet
Bengt M Eriksson, MD
Hyperbaric Medicine, Karolinska Univ Hosp
Primary Completion
October 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
December 2, 2020
Record last verified: 2020-11
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Source: ClinicalTrials.gov.
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