Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07535164

Hyperbaric Oxygen Therapy as Adjunctive Treatment for Fracture-Related Infection

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Fracture Related Infection Hyperbaric Oxygenation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Amsterdam UMC

Amsterdam, North Holland, 1105AZ, Netherlands

Location contact

Silke D de Wolde, MD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hyperbaric Oxygen Therapy

Drug

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 outcomes

  1. Number of subjects included

    Time frame: 1 year

    The total number of subjects included at the end of the inclusion period (i.e. one year after the start of the study)

  2. Number of HBOT sessions completed by each subject in the intervention group

    Time frame: Within 30 days after the first HBOT session

  3. 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

  4. 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

Other outcomes

  1. EQ-5D-5L scores

    Time frame: At baseline and 6 weeks, 3 months, 6 months, and 1 year after the initial surgery in the context of FRI treatment

    Quality of life will be assessed using the five level version of the EuroQol Five Dimensions questionnaire (EQ-5D-5L). The index value can range between below 0 and 1. A higher score indicates a better quality of life.

  2. EQ-VAS scores

    Time frame: At baseline and 6 weeks, 3 months, 6 months, and 1 year after the initial surgery in the context of FRI treatment

    Quality of life will be assessed using the EuroQol Visual Analogue Scale (EQ-VAS). The questionnaire score can range between 0 and 100. A higher score indicates a better outcome.

  3. LIMB-Q scores

    Time frame: At baseline and 6 weeks, 3 months, 6 months, and 1 year after the initial surgery in the context of FRI treatment

    The subsets function, symptoms, physiological and work of the LIMB-Q questionnaire (a PROM validated for use in lower extremity trauma) will be assessed. The questionnaire score can range between 0 and 100. A higher scores indicates a better outcome.

  4. Time to return to life role

    Time frame: From the initial surgery for FRI treatment to study completion at 1 year

    A self-designed questionnaire will be used to assess the time to return to life role for each subject. Life role is defined as executing structural (daily to weekly) activities, such as labour, informal care, or volunteer work. A longer time to return to life role implicates a longer recovery period.

  5. Number of recurrence(s) of infection

    Time frame: From the initial surgery for FRI treatment to study completion at 1 year

    The number of recurrence(s) of infection, defined as reappearance of a confirmatory FRI criterium after completing the initial surgical and antibiotic FRI treatment, occured during the follow-up period will be assessed.

  6. Number of repeat surgeries

    Time frame: From the initial surgery for FRI treatment to study completion at 1 year

    The number of repeat surgeries performed in the context of FRI treatment during the follow-up period will be assessed.

  7. Number of soft tissue reconstruction failures

    Time frame: From the initial surgery for FRI treatment to study completion at 1 year

    The number of soft-tissue reconstructions which have failed during the follow-up period will be assessed.

  8. Number of amputations

    Time frame: From the initial surgery for FRI treatment to study completion at 1 year

    The number of amputations performed (in the context of FRI treatment/obtaining infection control) during the follow-up period will be assessed.

  9. Change in CRP levels

    Time frame: From the initial surgery for FRI treatment to study completion at 1 year

    Laboratory findings on C-reactive protein (CRP) as collected in the context of standard care during the follow-up period will be assessed.

  10. Change in WBC counts

    Time frame: From the initial surgery for FRI treatment to study completion at 1 year

    Laboratory findings on white blood cell (WBC) counts as collected in the context of standard care during the follow-up period will be assessed.

  11. Change in ESR levels

    Time frame: From the initial surgery for FRI treatment to study completion at 1 year

    Laboratory findings on the erythrocyte sedimentation rate (ESR) as collected in the context of standard care during the follow-up period will be assessed.

  12. Number of subjects with remission of infection

    Time frame: One year after the initial surgery for FRI treatment

    The number of subjects with remission of infection, defined as absence of all confirmatory criteria and suggestive signs for FRI and no use of antibiotics since >7 days, will be assessed.

  13. Number of subjects with non-union

    Time frame: One year after the initial surgery for FRI treatment

  14. Number of subjects with complete wound healing

    Time frame: One year after the initial surgery for FRI treatment

Study contacts

Contact information is provided by the study sponsor or research team.

Robert P Weenink, MD PhD

CONTACT

[email protected]

+31205669111

Sponsors and collaborators

Lead sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Other

Collaborators

  • Stichting ZiektekostenVerzekering Krijgsmacht

Registry information

Official study title

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

Acronym: SOLDIER

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 16, 2026
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.