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| ID | Type | Description | Link |
|---|---|---|---|
| 2026-525871-24-00 | EU Trial (CTIS) Number |
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| Name | Class |
|---|---|
| Stichting ZiektekostenVerzekering Krijgsmacht | UNKNOWN |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hyperbaric oxygen therapy (HBOT) + standard care | Experimental | 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. |
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| Standard care | No Intervention | Subjects receive standard care, consisting of at least surgical debridement of the FRI and administration of antibiotics. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyperbaric Oxygen Therapy | Drug | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 1 year |
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | At baseline and 6 weeks, 3 months, 6 months, and 1 year after the initial surgery in the context of FRI treatment |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Robert P Weenink, MD PhD | Contact | +31205669111 | r.p.weenink@amsterdamumc.nl |
| Name | Affiliation | Role |
|---|---|---|
| Markus W Hollmann, MD PhD PhD Professor | Amsterdam UMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amsterdam UMC | Amsterdam | North Holland | 1105AZ | Netherlands |
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| ID | Term |
|---|---|
| D006931 | Hyperbaric Oxygenation |
| ID | Term |
|---|---|
| D010102 | Oxygen Inhalation Therapy |
| D012138 | Respiratory Therapy |
| D013812 | Therapeutics |
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| 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. |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | One year after the initial surgery for FRI treatment |
| Number of subjects with non-union | One year after the initial surgery for FRI treatment |
| Number of subjects with complete wound healing | One year after the initial surgery for FRI treatment |