Necrotizing soft-tissue infection (NSTI) is a rare, severe, fast-progressing bacterial infection within the soft tissue compartment. The NSTI mortality rate remain high and largely unaltered in the last decades. The standard of care in NSTI is multidisciplinary and includes surgery, intensive care, and broad-spectrum antibiotics. Hyperbaric oxygen (HBO2) treatment is an adjunctive treatment potentially improving survival, but is not standard of care in many centres, presumably as no evidence of its benefit from randomized clinical trial exists.
The primary objective of this trial, HOT-NSTI, is to investigate the effect of adjunctive HBO2 treatment on 30-day all-cause mortality in patients with NSTI.
Adults (age ≥18 years)
Surgical confirmed NSTI (defined by perioperative tissue characteristics observed by the surgeon. The diagnosis is based on sign as necrotic or deliquescent soft tissue with widespread undermining of the surrounding tissue)
Contraindications for HBO2 treatment according to local protocol (e.g., undrained pneumothorax)
Confirmed pregnancy
Referred to palliative care
Previously randomized into the HOT-NSTI trial
Ole Hyldegaard
Lead sponsor
Rigshospitalet, Denmark
Sponsor institution
Københavns Universitet
Collaborator
AZ Sint-Lucas Brugge
Collaborator
Ziekenhuis Oost-Limburg
Collaborator
University Hospital, Antwerp
Collaborator
Rigshospitalet, Denmark
Collaborator
Oslo University Hospital
Collaborator
Haukeland University Hospital
Collaborator
Turku University Hospital
Collaborator
Karolinska University Hospital
Collaborator