A necrotising soft tissue infection (NSTI) is a severe infection of the skin and underlying tissues that leads to necrosis of skin and fat tissue. Patients with NSTI have a high mortality risk even with an adequate treatment including timely surgical intervention, antibiotics and intensive care. Moreover, mutilating surgery such as limb amputation is often necessary to prevent death.
Hyperbaric oxygen therapy (HBO therapy) is a promising adjunctive treatment for patients with NSTI. HBO therapy has immune modulating and antibacterial effects that may contribute to faster recovery and improved survival in patients with NSTI. However, to date, no randomised studies have been conducted to compare additional treatment with HBO therapy alongside standard care with standard care alone.
The HOT-NSTI study is an international trial in which centers with expertise in NSTI and HBO therapy randomise patients with NSTI to either standard therapy supplemented with HBO therapy, or standard therapy alone. It aims to study the reduction in mortality at 30 days, as well the reduction in amputations. A total of nearly 1,500 patients will be enrolled in hospitals in Denmark, Sweden, Norway, Finland, Belgium, France, Australia and Canada.
| 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€ |
| Sponsor | Rigshospitalet (Denmark) |
| Chief Investigator | Prof. Dr Symen Ligthart |
| BCC | UZA |
| Number of participating sites | 3 |