NCT07535164

Hyperbaric Oxygen Therapy as Adjunctive Treatment for Fracture-Related Infection

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2026-08-01
• Primary completion: 2028-08-01
• Completion: 2028-08-01
• First posted: 2026-04-16
• Last updated: 2026-04-16

Locations

1 site across 1 country: Netherlands