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Not yet recruiting NCT07535164

Hyperbaric Oxygen Therapy as Adjunctive Treatment for Fracture-Related Infection

Phase II Interventional Fracture Related Infection Hyperbaric Oxygenation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Hyperbaric Oxygen Therapy.
Who it may be relevant to
Registry conditions: Fracture Related Infection, Hyperbaric Oxygenation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Supplementary Oxygen Therapy After Limb Debridement and Reconstruction Surgery in Infected Extremity Fractures (SOLDIER): a Pilot, Non-blinded, Randomized Controlled Trial

Overview

A fracture-related infection (FRI) is a difficult to treat condition in which a bone fracture and surrounding tissues are infected. This results in impaired healing and ongoing symptoms such as pain, wound leakage and swelling, which affects patients' functioning and quality of life. Despite adequate treatment in the form of extensive surgical debridement and long-term antibiotics, it is hard to obtain infection eradication. This pilot, non-blinded, randomized controlled trial (RCT) will assess the feasibility of a subsequent, larger RCT, in which hyperbaric oxygen therapy (HBOT) will be investigated as potential treatment modality for FRI in adjunction to standard care. HBOT induces an increased oxygen tension in the body and thereby inhibits inflammation and the growth of several bacteria. Furthermore, it stimulates bone and blood vessel formation. Therefore, HBOT might be of added value in the treatment of FRI. Data on process-related outcomes, patient-reported outcome measures, and clinical parameters are obtained during this pilot study to determine whether a subsequent study investigating the efficacy of HBOT is viable.

Interventions

  • Drug Hyperbaric Oxygen Therapy
    Each HBOT session will be conducted in accordance with the following protocol: three 20 minute blocks and one 15 minute block of 100% oxygen breathing at 2.4 ATA, split up by 5 minutes of oxygen rest (i.e. breathing air with 21% oxygen at 2.4 ATA)

Primary outcome measures

  • Number of subjects included [Time frame: 1 year]
  • Number of HBOT sessions completed by each subject in the intervention group [Time frame: Within 30 days after the first HBOT session]
  • Amount of missing data per PROM per time point [Time frame: At baseline and 6 weeks, 3 months, 6 months, and 1 year after the initial surgery in the context of FRI treatment]
  • Number of complete questionnaires per PROM per timepoint [Time frame: At baseline and 6 weeks, 3 months, 6 months, and 1 year after the initial surgery in the context of FRI treatment]

Eligibility criteria

Inclusion criteria

  • Age ≥ 18 years
  • Confirmed or highly suspected post-traumatic FRI of the lower limb, for which surgical intervention will be conducted

Exclusion criteria

  • Patients with a known contraindication for HBOT: untreated pneumothorax; epilepsy; middle ear or thorax surgery in the previous 12 months; inability to equalize the ears; COPD grade 4 or other severe air trapping lung disease; presence of a device that is not known to be compatible with HBOT; severe claustrophobia; pregnancy; BMI ≥ 35; obstructive sleep apnoea syndrome or obesity hypoventilation syndrome with a chronic increased PaCO2 > 6.4 kPa
  • Patients with an early (i.e. diagnosed <6 weeks post initial trauma) FRI, which is treated by DAIR-procedure (Debridement, Antibiotics, Implant Retention) without soft tissue reconstruction
  • Patients with an active isolation precautions protocol which is incompatible with treatment in a hyperbaric chamber (i.e. with multiple patients in the chamber at the same time)
  • Inability to understand Dutch or English

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Netherlands · 1 center
  • Amsterdam UMC — Amsterdam

Identifiers

NCT: NCT07535164 · SOLDIER-2026 · 2026-525871-24-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗