Condition category
Musculoskeletal Diseases
Date applied
11/09/2008
Date assigned
23/10/2008
Last edited
22/12/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Gunther Hofmann

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

GENTA-COLL study

Study hypothesis

Local application of GENTA-COLL resorb® reduces the amount of operative revisions in the treatment of acute and chronic osteomyelitis.

Ethics approval

Ethics committee of University Jena gave approval on the 15th February 2008 (ref: 2202-01/08)

Study design

Prospective randomised single-blind two centre therapy-optimisation trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

15/02/2008

Overall trial end date

15/02/2011

Reason abandoned

Lack of participants

Eligibility

Participant 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

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

320

Participant 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

Recruitment start date

15/02/2008

Recruitment end date

15/02/2011

Locations

Countries of recruitment

Germany

Trial participating centre

Klinikum der Friedrich Schiller Universitat Jena
Jena
07740
Germany

Sponsor information

Organisation

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

Sponsor details

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

Sponsor type

University/education

Website

http://www.uniklinikum-jena.de/Willkommen.html

Funders

Funder type

Industry

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes