Clinical trial NCT05185115: Efficacy of Nasal Oxygen Therapy to Reduce Postoperative Complications in Ankle Trauma Surgery in At-risk Patients: a Randomized Pilot Study.
Official title: Efficacy of Nasal Oxygen Therapy to Reduce Postoperative Complications in Ankle Trauma Surgery in At-risk Patients: a Randomized Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Ankle Fractures
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
Collaborators: name: Radiometer Medical ApS
First posted: 2022-01-11
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 "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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Cutaneous and infectious complications
timeFrame: 6 months
Secondary outcomes:
measure: Observer Scar Assessment Scale (OSAS questionnaire)
timeFrame: 3 weeks after surgery
measure: Observer Scar Assessment Scale (OSAS questionnaire)
timeFrame: 6 weeks after surgery
measure: Observer Scar Assessment Scale (OSAS questionnaire)
timeFrame: 12 weeks after surgery
measure: Revision surgery
timeFrame: 6 months after surgery
measure: Pseudoarthrosis Complication
timeFrame: 24 weeks after surgery
measure: Visual Analogue Scale (VAS) to evaluate ankle pain
timeFrame: preoperatively
measure: Visual Analogue Scale (VAS) to evaluate ankle pain
timeFrame: 24 hours after surgery
measure: Visual Analogue Scale (VAS) to evaluate ankle pain
timeFrame: 48 hours after surgery
measure: Visual Analogue Scale (VAS) to evaluate ankle pain
timeFrame: 3 weeks after surgery
measure: Visual Analogue Scale (VAS) to evaluate ankle pain
timeFrame: 6 weeks after surgery
measure: Visual Analogue Scale (VAS) to evaluate ankle pain
timeFrame: 12 weeks after surgery
measure: Visual Analogue Scale (VAS) to evaluate ankle pain
timeFrame: 24 weeks after surgery
measure: Transcutaneous oxygen pressure measurements (TcPO2)
timeFrame: before the initiation of oxygen therapy preoperatively
measure: Transcutaneous oxygen pressure measurements (TcPO2)
timeFrame: 48hours after surgery
measure: Transcutaneous oxygen pressure measurements (TcPO2)
timeFrame: 3 weeks after surgery
measure: EuroQol 5-Dimension (EQ-5D) self-questionnaire
timeFrame: pre-operatively
measure: EuroQol 5-Dimension (EQ-5D) self-questionnaire
timeFrame: 48 hours after surgery
measure: EuroQol 5-Dimension (EQ-5D) self-questionnaire
timeFrame: 3 weeks after surgery
measure: EuroQol 5-Dimension (EQ-5D) self-questionnaire
timeFrame: 6 weeks after surgery
measure: EuroQol 5-Dimension (EQ-5D) self-questionnaire
timeFrame: 12 weeks after surgery
measure: EuroQol 5-Dimension (EQ-5D) self-questionnaire
timeFrame: 24 weeks after surgery
Other outcomes:
Locations:
city: Nantes
country: France
facility: Dr Gadbed
Study officials:
References: