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Efficacy of nasal oxygen therapy on the reduction of postoperative complications in ankle trauma surgery in at-risk patients: a randomized pilot study
EU CTIS ID: 2024-516578-31-00
What this study is testing
To compare the complication rate of "at risk" patients who underwent trauma surgery of the ankle between 2 groups. Patients with at least one comorbidity and/or complex fracture were defined as "at risk": - Patient with a comorbidity defined at risk by the literature (Bhandari et al, 2004; Flynn et al, 2000): diabetes, smoking, peripheral neuropathy, obstructive arterial disease of the lower limbs (AOMI), microangiopathy, treatment influencing healing (chemotherapy, corticosteroids...) - Patient with a complex fracture. Complex fractures are defined as dislocated bimalleolar fractures, trimalleolar fractures, distal quarter leg fractures, tibial pilon fractures, talus fractures and open fractures
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patient over 18 years of age
- Patient with at least one risk factor for scarring complications such as comorbidity(ies) and/or complex fracture
- Patient with at least one risk factor for scar complication, such as comorbidity(ies) and/or complex fracture: - Patient with a comorbidity defined as at risk in the literature (Bhandari et al, 2004; Flynn et al, 2000): diabetes, smoking, peripheral neuropathy, obstructive arterial disease of the lower limbs (AOMI), microangiopathy, treatment influencing healing (chemotherapy, corticosteroids, etc.). - Patients with complex fractures. Complex fractures include dislocated bimalleolar fractures, trimalleolar fractures, fractures of the distal quarter of the leg, tibial pilon fractures, talus fractures and open fractures.
You likely can't join if
- Patient with chronic respiratory failure
- Patient with sleep apnea
- Patient with a bilateral ankle fracture
- Patient with polytrauma
- Patient on long-term oxygen therapy
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.