Hyperbaric Oxygen Therapy as Adjunctive Treatment for Fracture-Related Infection (SOLDIER)

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

Status and phase: Begins enrollment in 3 months; Phase 2

Conditions: Fracture Related Infection; Hyperbaric Oxygenation

Treatments: Drug: Hyperbaric Oxygen Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07535164

SOLDIER-2026

2026-525871-24-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Hyperbaric oxygen therapy (HBOT) + standard care

Experimental group

Description:

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.

Treatment:

Drug: Hyperbaric Oxygen Therapy

Standard care

No Intervention group

Description:

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