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Adjunctive Hyperbaric Oxygen Treatment for Patients With Necrotizing Soft-Tissue Infection (HOT-NSTI Trial)

Status: Recruiting
Location: See location...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
Belgium
University Hospital Antwerpen
RECRUITING
Antwerp
Time Frame
Start Date: 2026-04-04
Estimated Completion Date: 2033-06-30
Participants
Target number of participants: 1480
Treatments
Active_comparator: Standard of care
standard of care (e.g. intensive care, surgery, antibiotics)
Experimental: Standard of care + hyperbaric oxygen treatment
standard of care (e.g. intensive care, surgery, antibiotics) + hyperbaric oxygen treatment
Related Therapeutic Areas
Sponsors
Collaborators: Haukeland University Hospital, AZ Sint-Lucas Brugge, Karolinska University Hospital, Københavns Universitet, Oslo University Hospital, University Hospital, Antwerp, Turku University Hospital, Ziekenhuis Oost-Limburg, Rigshospitalet, Denmark
Leads: Ole Hyldegaard

This content was sourced from clinicaltrials.gov