Stopped: low enrollment
This study is being conducted to assess the utility of hyperbaric oxygen as an adjunctive treatment to reduce postoperative complications. It is hypothesized that HBO2 given in the immediate postoperative period will reduce postoperative complications in patients undergoing below-the-knee amputations. The objective of this study will be to compare treatment and standard care groups, randomly created of eligible patients, to compare their postoperative complications and to assess their postoperative hospital length of stay, 90-day mortality, failure to heal at 4 and 8 week follow-up visits and ability to ambulate with a prosthesis at 6 months post amputation.
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Number of Participants With Mortality During the Inpatient Period
Timeframe: During inpatient stay immediately after amputation, up to 13 days
Number of Participants With Re-operation
Timeframe: Up to 90 days after amputation
Number of Participants With Wound Infection
Timeframe: Up to 90 days after amputation