Fracture Related Infection, Hyperbaric Oxygenation
Conditions
Keywords
Hyperbaric oxygen therapy, Fracture-related infection, Lower extremity, Feasibility studies, Randomized controlled trial
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.
Interventions
DRUGHyperbaric 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)
Sponsors
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Stichting ZiektekostenVerzekering Krijgsmacht
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of subjects included | 1 year | 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 | 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 | — |
Countries
Netherlands
Contacts
CONTACTRobert P Weenink, MD PhD
PRINCIPAL_INVESTIGATORMarkus W Hollmann, MD PhD PhD Professor
Amsterdam UMC
Outcome results
None listed