Hyperbaric Oxygen Therapy as Adjunctive Treatment for Fracture-Related Infection

NCT07535164 | Not Yet Recruiting Phase 2

• 2 other identifiers: SOLDIER-20262026-525871-24-00
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fracture Related Infection; Hyperbaric Oxygenation

Keywords

Hyperbaric oxygen therapy; Fracture-related infection; Lower extremity; Feasibility studies; Randomized controlled trial

Outcome Measures

Primary Outcomes (4)

• Number of subjects included

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

  1 year

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

  Within 30 days after the first HBOT session

• Amount of missing data per PROM per time point

  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

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

Other Outcomes (14)

• EQ-5D-5L scores

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

• EQ-VAS scores

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

• LIMB-Q scores

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

Study Arms (2)

Hyperbaric oxygen therapy (HBOT) + standard care

EXPERIMENTAL

Subjects receive 20 HBOT sessions within 30 days in addition to standard care. The first HBOT session will be conducted within 7 days after the index surgery in the context of FRI treatment.

Drug: Hyperbaric Oxygen Therapy

Standard care

NO INTERVENTION

Subjects receive standard care, consisting of at least surgical debridement of the FRI and administration of antibiotics.

Interventions

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)

Hyperbaric oxygen therapy (HBOT) + standard care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead
• Stichting ZiektekostenVerzekering Krijgsmacht: collaborator

Study Sites (1)

Amsterdam UMC

Amsterdam, North Holland, 1105AZ, Netherlands

Location

MeSH Terms

Interventions

Hyperbaric Oxygenation

Intervention Hierarchy (Ancestors)

Oxygen Inhalation Therapy; Respiratory Therapy; Therapeutics

Study Officials

• Markus W Hollmann, MD PhD PhD Professor

  Amsterdam UMC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert P Weenink, MD PhD

CONTACT

+31205669111; r.p.weenink@amsterdamumc.nl

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD PhD Professor

Study Record Dates

• First Submitted: March 20, 2026
• First Posted: April 16, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: April 16, 2026

Record last verified: 2026-03

Locations

NL (1)