Clinical Trial

Efficacy of Nasal Oxygen Therapy to Reduce Postoperative Complications in Ankle Trauma Surgery in At-risk Patients: a Randomized Pilot Study.

Study acronym: TOP-ANK
Active, Not Recruiting Phase 3
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Summary
Ankle fractures are one of the most common surgeries in the world. After this kind of surgery, complications can occur, related to the scar or an infection. These complications are more frequent in "high-risk" patients. Nasal oxygen therapy is currently used in order to reduce these complications. However, no study proved its efficiency yet. In a cohort of 200 patients, one group will receive oxygen therapy during hospitalization, while the other will not. Complication rates will be observed up to 6 months after the operation
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2022-01-10; most recent amendment 2026-01-13.
Status change: Recruiting → Active, Not Recruiting 2026-01-13
Status change: Not Yet Recruiting → Recruiting 2023-11-14
Trial Details
NCT Number NCT05185115
Lead Sponsor Nantes University Hospital
Collaborators: Radiometer Medical ApS
Conditions Ankle Fractures
Enrollment 200 participants
Start Date 2022-04-09
Primary Completion 2026-10-01 (estimated)
Study Completion 2026-10-01 (estimated)
Updated on ClinicalTrials.gov 2026-01-14