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Study on Oxygen Therapy to Reduce Postoperative Complications in At-Risk Ankle Trauma Surgery Patients

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on patients undergoing surgery for ankle injuries, specifically those who are considered "at risk" due to certain health conditions or complex fractures. These conditions include diabetes, smoking, nerve damage in the legs, and diseases affecting blood flow, among others. Complex fractures may involve multiple broken bones in the ankle or leg. The study aims to see if using nasal oxygen therapy can help reduce complications after surgery for these patients.

The treatment being studied is the use of oxygen as a medicinal gas, which is inhaled through the nose. This therapy is being tested to see if it can lower the chances of problems like skin issues, infections, and poor healing of surgical scars. The study will compare two groups of patients: one receiving the oxygen therapy and the other not receiving it, to see if there is a difference in the rate of complications.

Participants in the study will be monitored for up to six months after their surgery. During this time, researchers will check for any skin or infection issues, assess the healing of scars, and measure pain levels. The study will also look at the overall cost-effectiveness of using oxygen therapy in these cases. The goal is to find out if this treatment can make recovery easier and safer for patients with ankle injuries who have additional health risks.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on age and risk factors related to ankle surgery. These factors include certain health conditions or complex fractures.

  2. Step 2

    Pre-operative assessment

    Before surgery, a pre-operative assessment is conducted. This includes measuring TcPO2, which is the level of oxygen in the tissues, for a subgroup of patients.

  3. Step 3

    Surgery and initial recovery

    The surgery is performed on the ankle. Post-surgery, nasal oxygen therapy is administered to help reduce complications. This involves inhaling medicinal oxygen gas.

  4. Step 4

    Post-operative monitoring

    Monitoring occurs at various intervals: 24 hours, 48 hours, 3 weeks, 6 weeks, 12 weeks, and 24 weeks after surgery. This includes assessing pain levels and checking for any skin or infection issues.

    The Observer Scar Assessment Scale (OSAS) questionnaire is used at weeks 3, 6, and 12 to evaluate scar healing.

  5. Step 5

    Follow-up assessments

    Follow-up assessments include checking for delayed bone healing at 12 weeks and potential pseudarthrosis at 24 weeks. These are evaluated through radiographs.

    The EQ-5D self-questionnaire is used to assess quality of life at various points, including pre-operatively and at 48 hours, 3 weeks, 6 weeks, 12 weeks, and 24 weeks post-surgery.

  6. Step 6

    Completion of study participation

    Participation in the study concludes after 24 weeks, with a final assessment of any complications and overall recovery.

Who can join the trial?

4 criteria

  • Patient must be over 18 years of age.
  • Patient must have at least one risk factor for scarring complications. This can be a **comorbidity** or a **complex fracture**.
  • Comorbidities include conditions like **diabetes**, **smoking**, **peripheral neuropathy** (nerve damage in the arms and legs), **obstructive arterial disease of the lower limbs** (poor blood flow in the legs), **microangiopathy** (damage to small blood vessels), or treatments that affect healing like **chemotherapy** or **corticosteroids** (medications that reduce inflammation).
  • Complex fractures include **dislocated bimalleolar fractures** (breaks in two bones of the ankle), **trimalleolar fractures** (breaks in three bones of the ankle), **fractures of the distal quarter of the leg** (breaks in the lower part of the leg), **tibial pilon fractures** (breaks at the bottom of the shinbone), **talus fractures** (breaks in a small bone in the ankle), and **open fractures** (breaks where the bone pierces the skin).

Who cannot join the trial?

4 criteria

  • Patients who do not have any of the following conditions: **diabetes**, **smoking**, **peripheral neuropathy** (a condition where nerves in the body are damaged), **obstructive arterial disease of the lower limbs** (a condition where blood flow in the legs is reduced), **microangiopathy** (damage to small blood vessels), or are not undergoing treatments that affect healing like **chemotherapy** or **corticosteroids**.
  • Patients who do not have a **complex fracture**. Complex fractures include **dislocated bimalleolar fractures** (a type of ankle fracture), **trimalleolar fractures** (another type of ankle fracture), **distal quarter leg fractures** (fractures in the lower part of the leg), **tibial pilon fractures** (fractures at the bottom of the shinbone), **talus fractures** (fractures in a bone in the ankle), and **open fractures** (fractures where the bone breaks through the skin).
  • Patients who are not within the specified age range for the study.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.
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Investigated drugs

Nasal Oxygen Therapy is being studied to see if it can help reduce complications after ankle surgery in patients who are considered "at risk." These patients may have conditions like diabetes, smoking habits, or complex fractures that could make recovery more difficult. The therapy involves providing oxygen through the nose to improve healing and reduce the chance of complications after surgery.

What is already known about the treatment

Oxygen Therapy – Oxygen therapy is administered through a nasal cannula, which is a small, flexible tube placed in the nostrils. It is currently being studied for its effectiveness in reducing postoperative complications in patients undergoing ankle trauma surgery, particularly those with additional health risks such as diabetes or complex fractures. The main therapeutic indication is to improve oxygen levels in the blood, which can aid in healing and reduce the risk of complications after surgery. At the molecular level, oxygen therapy works by increasing the amount of oxygen available to tissues, which is essential for cellular metabolism and repair processes. It is classified as a supportive therapy in the management of surgical patients.

Investigated diseases

  • Diabetes Mellitus

    A chronic condition characterized by high levels of sugar in the blood due to the body's inability to produce or effectively use insulin. Over time, high blood sugar levels can lead to damage of various organs and systems, particularly the nerves and blood vessels. It often progresses with symptoms such as increased thirst, frequent urination, and fatigue. If not managed, it can result in complications affecting the heart, eyes, kidneys, and feet.

  • Peripheral Neuropathy

    A disorder that occurs when nerves outside the brain and spinal cord are damaged, often causing weakness, numbness, and pain, usually in the hands and feet. It can result from various causes, including diabetes, infections, and exposure to toxins. The condition may progress slowly, with symptoms worsening over time, potentially leading to difficulties in movement and coordination.

  • Obstructive Arterial Disease of the Lower Limbs

    A condition where blood flow to the legs is reduced due to narrowed or blocked arteries, often caused by atherosclerosis. This can lead to symptoms such as leg pain when walking, known as claudication, and can progress to more severe pain at rest. If untreated, it may result in tissue damage and ulcers due to insufficient blood supply.

  • Microangiopathy

    A disease affecting the small blood vessels, often seen in conditions like diabetes, where the walls of these vessels become thickened and weakened. This can lead to reduced blood flow and oxygen delivery to tissues, potentially causing damage to organs such as the eyes and kidneys. Over time, it may contribute to complications like retinopathy and nephropathy.

  • Complex Fractures

    These are severe bone fractures that involve multiple breaks or are associated with dislocation, often requiring surgical intervention. They can include bimalleolar, trimalleolar, and tibial pilon fractures, among others. The healing process can be prolonged and complicated, with a risk of delayed union or non-union of the bone.

  • Open Fractures

    A type of fracture where the bone breaks through the skin, creating an open wound. This condition poses a higher risk of infection and requires prompt medical treatment to prevent complications. Healing can be complex, often involving surgical repair and extended recovery time.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516578-31-00Protocol codeRC21_0129Estimated enrolment200 patientsSponsorCentre Hospitalier Universitaire De Nantes

sourced from the EU Clinical Trials Register and site verification

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