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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
StatusActive, Not Recruiting
PhasePhase 3
Started2022-04-09
View on ClinicalTrials.gov ↗
Record status
This record was last updated January 14, 2026 (before its estimated October 1, 2026 completion). Its status may not reflect the trial's current state.

Amendment history

2026-01-13
Recruiting→Active, Not Recruiting Study Status, Oversight, Contacts/Locations v3
Trial statusRecruiting→Active, Not Recruiting
Study sitesdetails revised at 1 of 1 site
2024-11-26
Study Status, Oversight, Contacts/Locations v2
Primary completion date2024-07-01→2026-10-01
Completion date2024-07-01→2026-10-01
Study sitesdetails revised at 1 of 1 site
2023-11-14
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2022-02-01→confirmed 2022-04-09
Study sitesdetails revised at 1 of 1 site
2022-01-10
Original filing
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
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