Acute and chronic osteomyelitis Musculoskeletal Diseases Osteomyelitis
Conditions
Interventions
Patients with acute or chronic osteomyelitis localised in the shaft of a long bone and randomised into the treatment arm undergo surgery and will be treated with GENTA-COLL resorb® which is a local an
Sponsors
Friedrich Schiller University Jena (Friedrich-Schiller-Universitat Jena) (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with acute and chronic osteomyelitis localised in the shaft of a long bone. Clinical and laboratory inflammation parameters must be present. 2. Aged greater than or equal to 18 years, either sex 3. Written informed consent of the patient
Exclusion criteria
Exclusion criteria: 1. Joint infection and infiltration of osteomyelitis into the joint, respectively 2. Periprosthetic infection ("Endoprosthesis infection") 3. Osteomyelitis on two or more locations within a patient 4. Known microbiologically proven resistance against gentamicin 5. Vacuum sealing in revision-induced soft tissue defect; application of vacuum therapy (no continuous vacuum) 6. Known concomitant diseases, e.g. renal insufficiency, immunological diseases (among others autoimmune disease), neuromuscular disorders (among others Parkinson disease, Myasthenia gravis), connective tissue disease 7. Contraindication to the planned therapy (e.g. known hypersensitivity to collagen and/or gentamicin or other aminoglycoside antibiotics) 8. Expected low compliance 9. Pregnant or nursing women 10. Women with child bearing potency (less than 2 years after last menstruation) without effective contraception (i.e. implants, injectables, combined oral contraceptives, some intra-uterine devices [IUDs] or vasectomised partner) up to three weeks after end of treatment during the conduct of the trial 11. Concomitant participation in other clinical trials 12. Inability to consent to trial participation or to answer to needed information (e.g. organic psychosyndrome, dementia) 13. At least one of the following concomitant medication: 13.1. Systemic administration of aminoglycoside antibiotics 13.2. Loop diuretics (e.g. furosemide or ethacrynic acid), diuretics (intravenously [i.v.]) 13.3. Simultaneous or consecutive systemic or topical application of potentially neurotoxic and/or nephrotoxic substances, e.g. cisplatinum, other aminoglycosides, streptomycin, cefaloridin, viomycin, polymyxin B or polymyxin E 13.4. Local use of beta-lactam antibiotics 13.5. Muscle relaxants (except for anaesthesia), e.g. d-tubocurarine, suxamethonium or pancuronium, ether
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Amount of operative revisions until reaching clinical infection free and complete germfree status. A follow-up phase of 1 year is planned with measures 1, 3, 6 and 52 weeks after hospital discharge. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time to reach clinical infection free (defined as not irritated soft tissue and no fistula and C-reactive protein [CRP] and leukocytes in normal range) and complete germfree (defined as tissue samples taken during the operation and analysed according to standardised microbiological tests result to be germfree) status 2. Incidence of exacerbation of the infection/required amputation during the intervention phase (assessed before each new surgery) 3. Incidence of re-infections during the follow-up phase 4. Time between hospital discharge and incidence of re-infection A follow-up phase of 1 year is planned with measures 1, 3, 6 and 52 weeks after hospital discharge. | — |
Countries
Germany
Outcome results
None listed