A Phase 2 interventional study of Hyperbaric Oxygen Therapy in Fracture Related Infection and Hyperbaric Oxygenation, sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). Not yet recruiting at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-16.
Sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Phase 2, Interventional, and Treatment
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.
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) is the lead sponsor of 512 studies on the registry; 178 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: Hyperbaric Oxygen Therapy
Subjects receive standard care, consisting of at least surgical debridement of the FRI and administration of antibiotics.
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)
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)
Time frame: 1 year
Number of HBOT sessions completed by each subject in the intervention group
Time frame: Within 30 days after the first HBOT session
Amount of missing data per PROM per time point
Time frame: 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
Time frame: At baseline and 6 weeks, 3 months, 6 months, and 1 year after the initial surgery in the context of FRI treatment
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.
Time frame: At baseline and 6 weeks, 3 months, 6 months, and 1 year after the initial surgery in the context of FRI treatment
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.
Time frame: At baseline and 6 weeks, 3 months, 6 months, and 1 year after the initial surgery in the context of FRI treatment
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 frame: At baseline and 6 weeks, 3 months, 6 months, and 1 year after the initial surgery in the context of FRI treatment
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.
Time frame: From the initial surgery for FRI treatment to study completion at 1 year
Number of recurrence(s) of infection
The number of recurrence(s) of infection, defined as reappearance of a confirmatory FRI criterium after completing the initial surgical and antibiotic FRI treatment, occured during the follow-up period will be assessed.
Time frame: From the initial surgery for FRI treatment to study completion at 1 year
Number of repeat surgeries
The number of repeat surgeries performed in the context of FRI treatment during the follow-up period will be assessed.
Time frame: From the initial surgery for FRI treatment to study completion at 1 year
Number of soft tissue reconstruction failures
The number of soft-tissue reconstructions which have failed during the follow-up period will be assessed.
Time frame: From the initial surgery for FRI treatment to study completion at 1 year
Number of amputations
The number of amputations performed (in the context of FRI treatment/obtaining infection control) during the follow-up period will be assessed.
Time frame: From the initial surgery for FRI treatment to study completion at 1 year
Change in CRP levels
Laboratory findings on C-reactive protein (CRP) as collected in the context of standard care during the follow-up period will be assessed.
Time frame: From the initial surgery for FRI treatment to study completion at 1 year
Change in WBC counts
Laboratory findings on white blood cell (WBC) counts as collected in the context of standard care during the follow-up period will be assessed.
Time frame: From the initial surgery for FRI treatment to study completion at 1 year
Change in ESR levels
Laboratory findings on the erythrocyte sedimentation rate (ESR) as collected in the context of standard care during the follow-up period will be assessed.
Time frame: From the initial surgery for FRI treatment to study completion at 1 year
Number of subjects with remission of infection
The number of subjects with remission of infection, defined as absence of all confirmatory criteria and suggestive signs for FRI and no use of antibiotics since \>7 days, will be assessed.
Time frame: One year after the initial surgery for FRI treatment
Number of subjects with non-union
Time frame: One year after the initial surgery for FRI treatment
Number of subjects with complete wound healing
Time frame: One year after the initial surgery for FRI treatment
This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)