Efficacy of Nasal Oxygen Therapy to Reduce Postoperative Complications in Ankle Trauma Surgery in At-risk Patients: a Randomized Pilot Study.

Study Overview
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Brief Summary
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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

Detailed Description
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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 oxygen therapy. Patients in the experimental group will receive the oxygen just before the operation, and during the hospitalization. The rest of the care is the same for the 2 groups. Comparison of complication rate, of quality of healing, rate of revision surgery, delay in bone healing, rate of pseudoarthrosis, and ankle pain will be done between the 2 groups during a postoperative period of 6 months. A cost-utility analysis will also be realized. In a subgroup of 40 patients, additional transcutaneous oxygen pressure measurements will be performed to compare the evolution of tissue oxygenation between the 2 groups.

Official Title
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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

Conditions
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Ankle Fractures

Intervention / Treatment
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* Drug: Oxygen
* Other: no oxygen therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group (A)<br>Patients treated with 3 liters per minute oxygen delivered via nasal cannula duration hospitalization | Drug: Oxygen<br>* administration of oxygen at a flow rate of 3 liters per minute, via nasal cannula throughout the hospitalization.<br>* Other names: O2;|
| Other: Control group (B)<br>No oxygen therapy during hospitalization | Other: no oxygen therapy<br>* No oxygen therapy during hospitalization<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cutaneous and infectious complications | Post-surgery ankle complications including skin damage (ecchymosis, phlyctena), necrosis, superficial and deep infection and scar disunion | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Observer Scar Assessment Scale (OSAS questionnaire) | The OSAS grid is used to evaluate the tolerance and scar quality obtained by the operator. It is based on an evaluation of the healing process thanks to 7 questions whose answers are rated according to an increasing scale from 1 to 10 (1 corresponding to the best result and 10 the worst). The result will lead to a score of 7 to 70 points | 3 weeks after surgery | 
| Observer Scar Assessment Scale (OSAS questionnaire) | The OSAS grid is used to evaluate the tolerance and scar quality obtained by the operator. It is based on an evaluation of the healing process thanks to 7 questions whose answers are rated according to an increasing scale from 1 to 10 (1 corresponding to the best result and 10 the worst). The result will lead to a score of 7 to 70 points | 6 weeks after surgery | 
| Observer Scar Assessment Scale (OSAS questionnaire) | The OSAS grid is used to evaluate the tolerance and scar quality obtained by the operator. It is based on an evaluation of the healing process thanks to 7 questions whose answers are rated according to an increasing scale from 1 to 10 (1 corresponding to the best result and 10 the worst). The result will lead to a score of 7 to 70 points | 12 weeks after surgery | 
| Revision surgery |  | 6 months after surgery | 
| Pseudoarthrosis Complication | Presence of delayed healing on radiograph at S24 | 24 weeks after surgery | 
| Visual Analogue Scale (VAS) to evaluate ankle pain | The VAS measures the intensity of pain on a scale from 0 to 10 (0= no pain ans 10 = worst pain) | preoperatively | 
| Visual Analogue Scale (VAS) to evaluate ankle pain | The VAS measures the intensity of pain on a scale from 0 to 10 (0= no pain ans 10 = worst pain) | 24 hours after surgery | 
| Visual Analogue Scale (VAS) to evaluate ankle pain | The VAS measures the intensity of pain on a scale from 0 to 10 (0= no pain ans 10 = worst pain) | 48 hours after surgery | 
| Visual Analogue Scale (VAS) to evaluate ankle pain | The VAS measures the intensity of pain on a scale from 0 to 10 (0= no pain ans 10 = worst pain) | 3 weeks after surgery | 
| Visual Analogue Scale (VAS) to evaluate ankle pain | The VAS measures the intensity of pain on a scale from 0 to 10 (0= no pain ans 10 = worst pain) | 6 weeks after surgery | 
| Visual Analogue Scale (VAS) to evaluate ankle pain | The VAS measures the intensity of pain on a scale from 0 to 10 (0= no pain ans 10 = worst pain) | 12 weeks after surgery | 
| Visual Analogue Scale (VAS) to evaluate ankle pain | The VAS measures the intensity of pain on a scale from 0 to 10 (0= no pain ans 10 = worst pain) | 24 weeks after surgery | 
| Transcutaneous oxygen pressure measurements (TcPO2) | The Measurement of TcPO2 will be performed in a subgroup of 40 patients (20 patients in each group) | before the initiation of oxygen therapy preoperatively | 
| Transcutaneous oxygen pressure measurements (TcPO2) | The Measurement of TcPO2 will be performed in a subgroup of 40 patients (20 patients in each group) | 48hours after surgery | 
| Transcutaneous oxygen pressure measurements (TcPO2) | The Measurement of TcPO2 will be performed in a subgroup of 40 patients (20 patients in each group) | 3 weeks after surgery | 
| EuroQol 5-Dimension (EQ-5D) self-questionnaire | This quality of life questionnaire is completed in order to realize a cost-utility analysis (cost per QALY) | pre-operatively | 
| EuroQol 5-Dimension (EQ-5D) self-questionnaire | This quality of life questionnaire is completed in order to realize a cost-utility analysis (cost per QALY) | 48 hours after surgery | 
| EuroQol 5-Dimension (EQ-5D) self-questionnaire | This quality of life questionnaire is completed in order to realize a cost-utility analysis (cost per QALY) | 3 weeks after surgery | 
| EuroQol 5-Dimension (EQ-5D) self-questionnaire | This quality of life questionnaire is completed in order to realize a cost-utility analysis (cost per QALY) | 6 weeks after surgery | 
| EuroQol 5-Dimension (EQ-5D) self-questionnaire | This quality of life questionnaire is completed in order to realize a cost-utility analysis (cost per QALY) | 12 weeks after surgery | 
| EuroQol 5-Dimension (EQ-5D) self-questionnaire | This quality of life questionnaire is completed in order to realize a cost-utility analysis (cost per QALY) | 24 weeks after surgery |