OXYGEN for Ankle trauma|Ankle fracture

Inclusion criteria

• {"criterion_text":"-Patient over 18 years of age"}
• {"criterion_text":"-Patient with at least one risk factor for scarring complications such as comorbidity(ies) and/or complex fracture"}
• {"criterion_text":"-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."}

Exclusion criteria

• {"criterion_text":"-Patient with chronic respiratory failure"}
• {"criterion_text":"-Patient with sleep apnea"}
• {"criterion_text":"-Patient with a bilateral ankle fracture"}
• {"criterion_text":"-Patient with polytrauma"}
• {"criterion_text":"-Patient on long-term oxygen therapy"}

Primary endpoints

• {"endpoint_text":"-Cutaneous and infectious complications within 6 months postoperatively: skin suffering (ecchymosis, phlyctenes), necrosis, superficial and deep infection and scar disunion.","definition_or_measurement_approach":"Assessment of skin suffering (ecchymosis, phlyctenes), necrosis, superficial and deep infection and scar disunion within 6 months postoperatively."}

Secondary endpoints

• {"endpoint_text":"-Observer Scar Assessment Scale (OSAS) questionnaire, W3, W6 and W12","definition_or_measurement_approach":"OSAS questionnaire administered at week 3, week 6 and week 12."}
• {"endpoint_text":"-Surgical resumption within 6 months after surgery","definition_or_measurement_approach":"Recording of any surgical reintervention within 6 months postoperatively."}
• {"endpoint_text":"-Presence of delayed consolidation on radiograph at W12; and if so, presence of pseudarthrosis on radiograph at 24 weeks post-op (W24","definition_or_measurement_approach":"Radiographic assessment at week 12 for delayed consolidation and at week 24 for pseudarthrosis if delayed consolidation present."}
• {"endpoint_text":"-Pain VAS preoperatively, at H24, H48, W3, W6, W12 and W24","definition_or_measurement_approach":"Pain measured using Visual Analogue Scale pre-op, at 24h, 48h, week 3, week 6, week 12 and week 24."}
• {"endpoint_text":"-Measurement of TcPO2 before the start of oxygen therapy pre-operatively, then at H48, W3. These measurements will be performed in a subgroup of 40 patients (20 patients in each subgroup)","definition_or_measurement_approach":"TcPO2 measurements pre-operatively, at 48 hours and at week 3 in a subgroup of 40 patients (20 per subgroup)."}
• {"endpoint_text":"-Incremental cost-utility ratio over a 24-week time horizon (QALY assessed by EQ-5D self-questionnaire pre-operatively and at H48, W3, W6 and W12 and W24)","definition_or_measurement_approach":"Cost-utility analysis over 24 weeks; QALYs measured by EQ-5D self-questionnaire pre-op and at 48h, week 3, week 6, week 12 and week 24."}

France

Earliest CTIS Part Ii Submission Date

02-08-2024

Latest Decision Or Authorization Date

21-08-2024

Processing Time Days

19

Number Of Sites

1

Number Of Participants

200

Primary sponsor

Full Name

Centre Hospitalier Universitaire De Nantes

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France