Efficacy of nasal oxygen therapy on the reduction of postoperative complications in ankle trauma surgery in at-risk patients: a randomized pilot study

Conditions

Oxygen therapy in trauma ankle surgery patients

Brief summary

Cutaneous and infectious complications within 6 months postoperatively: skin suffering (ecchymosis, phlyctenes), necrosis, superficial and deep infection and scar disunion.

Detailed description

Observer Scar Assessment Scale (OSAS) questionnaire, W3, W6 and W12, Surgical resumption within 6 months after surgery, Presence of delayed consolidation on radiograph at W12; and if so, presence of pseudarthrosis on radiograph at 24 weeks post-op (W24, Pain VAS preoperatively, at H24, H48, W3, W6, W12 and W24, 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), 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)

Related papers

No related papers found yet.

Papers published before 2007-09-01 may not appear yet. Historical indexing is in progress.

Interventions

DRUGOXYGENE MEDICINAL LIQUIDE LINDE HEALTHCARE

DRUGgaz pour inhalation

DRUGpour évaporateur fixe et pour récipient cryogénique fixe

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Cutaneous and infectious complications within 6 months postoperatively: skin suffering (ecchymosis, phlyctenes), necrosis, superficial and deep infection and scar disunion.	—

Secondary

Measure	Time frame
Observer Scar Assessment Scale (OSAS) questionnaire, W3, W6 and W12, Surgical resumption within 6 months after surgery, Presence of delayed consolidation on radiograph at W12; and if so, presence of pseudarthrosis on radiograph at 24 weeks post-op (W24, Pain VAS preoperatively, at H24, H48, W3, W6, W12 and W24, 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), 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)	—

Measure

Time frame

Observer Scar Assessment Scale (OSAS) questionnaire, W3, W6 and W12, Surgical resumption within 6 months after surgery, Presence of delayed consolidation on radiograph at W12; and if so, presence of pseudarthrosis on radiograph at 24 weeks post-op (W24, Pain VAS preoperatively, at H24, H48, W3, W6, W12 and W24, 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), 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)

—

Countries

France

Outcome results

None listed