Status:
RECRUITING
Efficacy of Nasal Oxygen Therapy to Reduce Postoperative Complications in Ankle Trauma Surgery in At-risk Patients: a Randomized Pilot Study.
Lead Sponsor:
Nantes University Hospital
Collaborating Sponsors:
Radiometer Medical ApS
Conditions:
Ankle Fractures
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 "h...
Detailed Description
Prospective, single-center, comparative and randomized study based on a cohort of 200 patients with an ankle fracture. The patients will be assigned to one of the following group: with or without oxyg...
Eligibility Criteria
Inclusion
- Patient over 18 years of age
- Patient with an ankle joint injury with surgical indication
- Patient with at least one risk factor for scar complication such as comorbidity(ies) (diabetes, smoking, peripheral neuropathy, obstructive arterial disease of the lower limbs, microangiopathy, treatment influencing healing (chemotherapy, corticosteroids...)) and/or complex fracture
- Patient affiliated to a social security system
- Patient having signed an informed consent
Exclusion
- Patient with chronic respiratory insufficiency
- Patient with sleep apnea with equipment
- Patient under long term oxygen therapy
- Patient with a bilateral ankle fracture
- Polytrauma patients
- Pregnant or breastfeeding women or those refusing effective contraception
- Patient deprived of liberty or under legal protection (guardianship or curatorship)
- Patient unable to follow the protocol, as judged by the investigator
- Patient refusing to participate in the study
Key Trial Info
Start Date :
April 9 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT05185115
Start Date
April 9 2022
End Date
October 1 2026
Last Update
November 29 2024
Active Locations (1)
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1
Dr Gadbed
Nantes, France, France, 44000