Prospective randomised single-blind trial for application of GENTA-COLL resorb® for treatment of acute and chronic osteomyelitis

ISRCTN	ISRCTN74677374
DOI	https://doi.org/10.1186/ISRCTN74677374
Secondary identifying numbers	N/A

Submission date: 11/09/2008
Registration date: 23/10/2008
Last edited: 22/12/2010

Recruitment status: Stopped
Overall study status: Stopped
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Gunther Hofmann
Scientific

Klinikum der Friedrich Schiller Universitat Jena
Klinik fur Unfall-, Hand- und Wiederherstellungschirurgie
Erlanger Allee 101
Jena
07740
Germany

Study information

Study design	Prospective randomised single-blind two centre therapy-optimisation trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study acronym	GENTA-COLL study
Study objectives	Local application of GENTA-COLL resorb® reduces the amount of operative revisions in the treatment of acute and chronic osteomyelitis.
Ethics approval(s)	Ethics committee of University Jena gave approval on the 15th February 2008 (ref: 2202-01/08)
Health condition(s) or problem(s) studied	Acute and chronic osteomyelitis
Intervention	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 antibiotic therapy. After a few days a surgical revision will be performed, if needed, and treatment with GENTA-COLL resorb® will be repeated. This procedure will be repeated until no clinical or microbiological signs of infection are present for a patient. The control group will not be treated with the local antibiotic therapy. Please note that as of 22/12/2010 this record's status was changed to 'STOPPED' as recruitment of the required quantity of patients was not feasible.
Intervention type	Other
Primary outcome measure	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 outcome measures	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.
Overall study start date	15/02/2008
Completion date	15/02/2011
Reason abandoned (if study stopped)	Lack of participants

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Lower age limit	18 Years
Sex	Both
Target number of participants	320
Key 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
Key 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
Date of first enrolment	15/02/2008
Date of final enrolment	15/02/2011

Locations

Countries of recruitment

Germany

Study participating centre

Klinikum der Friedrich Schiller Universitat Jena

Jena
07740
Germany

Sponsor information

Friedrich Schiller University Jena (Friedrich-Schiller-Universitat Jena) (Germany)
University/education

c/o Prof. Dr. med. Dr. rer. nat. Gunther Hofmann
Klinik fur Unfall-, Hand- und Wiederherstellungschirurgie
Erlanger Allee 101
Jena
07740
Germany

Website	http://www.uniklinikum-jena.de/Willkommen.html
"ROR"	https://ror.org/05qpz1x62

Funders

Funder type

Industry

Resorba Wound Care (Wundversorgung) GmbH & Co. KG (Germany)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan