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.
Age ≥ 18 years
Confirmed or highly suspected post-traumatic FRI of the lower limb, for which surgical intervention will be conducted
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
Parallel
Hyperbaric Oxygen Therapy
DrugEach 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)
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)
Number of HBOT sessions completed by each subject in the intervention group
Amount of missing data per PROM per time point
Number of complete questionnaires per PROM per timepoint
EQ-5D-5L scores
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.
EQ-VAS scores
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.
LIMB-Q scores
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.
Time to return to life role
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.
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Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Lead sponsor
Stichting ZiektekostenVerzekering Krijgsmacht
Collaborator
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