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