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Supplementary Oxygen Therapy for Patients with Fracture-Related Infection After Limb Debridement and Reconstruction Surgery: A Pilot Randomized Trial

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

People who have an infected break in a bone, known as a Fracture-Related Infection, often need surgery to clean the wound and rebuild the limb. After this surgery, an extra treatment called hyperbaric oxygen therapy may be given, which involves breathing in a high concentration of oxygen through a mask or chamber to help the body heal.

The study aims to find out whether it is possible to run a larger trial that looks at the added benefit of this extra oxygen treatment. Participants are randomly assigned to either receive the supplemental oxygen sessions or to receive the usual care without the extra oxygen. The trial follows each person for several weeks after surgery, recording how many oxygen sessions are completed and collecting information on recovery and how they feel.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment confirmation

    After you join the study, a confirmation document is provided and a date for the first baseline visit is scheduled.

  2. Step 2

    Baseline assessment

    You undergo a baseline assessment that includes a review of medical history, physical examination, and collection of routine laboratory samples.

    The purpose is to document the condition of the fracture‑related infection before any study intervention.

  3. Step 3

    Randomization

    Based on a pre‑defined algorithm, you are assigned to either the oxygen intervention group or the control group.

    The assignment is recorded and communicated to the study team.

  4. Step 4

    Start of supplementary oxygen therapy

    If assigned to the intervention group, you begin receiving oxygen therapy by inhalation.

    The product is a 100 % (v/v) concentration of oxygen delivered through a mask or similar device.

  5. Step 5

    Oxygen therapy sessions

    You attend each scheduled therapy session as instructed by the study protocol.

    During each session, the inhaled concentration remains at 100 % oxygen.

    The frequency and total number of sessions are defined by the study design and are recorded for each participant.

  6. Step 6

    Monitoring during therapy

    Vital signs and any adverse symptoms are checked before, during, and after each oxygen session.

    Any observations are documented in the study record.

  7. Step 7

    Follow‑up assessments

    After the therapy period, you complete patient‑reported outcome questionnaires as specified in the protocol.

    Additional clinical evaluations may be performed to assess healing of the infection.

  8. Step 8

    Trial completion and data collection

    The final study visit includes collection of all remaining data, including the number of oxygen sessions completed and completeness of outcome measures.

    The study data are then compiled for analysis.

Who can join the trial?

3 criteria

  • Age: You must be 18 years old or older.
  • Fracture‑related infection (an infection that occurs after a bone break) must be confirmed by doctors or be strongly suspected, and it must be in the lower limb (the leg).
  • You must be scheduled to have a surgical intervention (an operation) to treat this infection.

Who cannot join the trial?

13 criteria

  • Untreated pneumothorax (air trapped around the lung) that makes hyperbaric oxygen therapy unsafe.
  • Epilepsy (a condition that causes seizures) that makes hyperbaric oxygen therapy unsafe.
  • Surgery on the middle ear or chest in the past 12 months that makes hyperbaric oxygen therapy unsafe.
  • Inability to equalize the ears (cannot balance ear pressure) that makes hyperbaric oxygen therapy unsafe.
  • Severe lung disease such as COPD grade 4 or other serious air‑trapping lung disease that makes hyperbaric oxygen therapy unsafe.
  • Having a medical device that is not known to be compatible with hyperbaric oxygen therapy.
  • Severe claustrophobia (extreme fear of closed spaces) that makes hyperbaric oxygen therapy unsafe.
  • Pregnancy.
  • Body mass index (BMI) of 35 or higher (obesity).
  • Obstructive sleep apnea syndrome or obesity hypoventilation syndrome with chronic high carbon dioxide level in the blood (PaCO2 > 6.4 kPa).
  • Early fracture‑related infection diagnosed less than 6 weeks after the initial injury that is treated only with a DAIR procedure (debridement, antibiotics, implant retention) without soft tissue reconstruction.
  • Active isolation precautions that cannot be followed in a hyperbaric chamber with other patients.
  • Inability to understand Dutch or English.
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Verified sites

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  • Verified

    Amsterdam UMC

    The NetherlandsAmsterdam, The Netherlands

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Investigated drugs

OXYGEN is a gas that the patients breathe in through a mask or tube after their limb surgery. In this trial, it is given as extra (supplementary) oxygen to help the body get more oxygen to the wound area. The idea is that higher levels of oxygen might improve healing and fight infection after the bone and tissue have been cleaned and rebuilt.

What is already known about the treatment

OXYGEN - Oxygen is given by inhalation, usually as a gas mixed at 100 % concentration delivered through a mask or a hyperbaric chamber. It is a well‑known medical gas that is widely used and described in many clinical guidelines. In this trial it is being tested for helping treat fracture‑related infection after surgery. Oxygen works by increasing the amount of oxygen in the blood, which improves tissue healing and helps immune cells kill bacteria; it is classified as a supplemental respiratory gas.

Investigated diseases

Fracture-related infection - Fracture-related infection is an infection that occurs at the site of a broken bone, often involving the bone or surrounding soft tissue. It usually develops after the injury or surgical fixation and can cause swelling, pain, and redness around the fracture. The infection may start quietly and gradually increase as bacteria multiply, leading to discharge from the wound. Over time the infected area can become more inflamed and may affect the stability of the healed bone. The condition can persist if the bacteria are not cleared, requiring ongoing monitoring.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2026-525871-24-00Protocol codeSOLDIER-2026Estimated enrolment50 patientsSponsorAmsterdam UMC

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