Zusammenfassung (Niederländisch oder Französisch oder Englisch)
Trial Description
| Title | Adjunctive Hyperbaric Oxygen Treatment for Patients with Necrotizing Soft-Tissue Infection (NSTI) |
| Participants (P) | This trial with include patients aged 18 years or more with a surgically confirmed NSTI diagnosis, with the exception of those referred to palliative care and those with a confirmed pregnancy, contraindications against HBO2 treatment (e.g. undrained pneumothorax), previous enrolment in the HOT-NSTI trial, allergy against study drug or known objections to participation in the trial. |
| Intervention (I) | usual care + adjunctive HBO2 treatment |
| Control (C) | Usual Care |
| Outcome (O) | 30-day all-cause mortality post-randomization |
| Trial Design | Investigator-initiated, pragmatic, international, multicentre, superiority, randomized, open-label, clinical trial |
| Sample Size | 1480 (90 in Belgium) |
| Trial duration | 66 months |
| Budget | 231.000€ |
Trial team
| Sponsor | Rigshospitalet (Denmark) |
| Chief Investigator | Prof. Dr Symen Ligthart |
| BCC | UZA |
| Number of participating sites | 3 |
