Optimisation of the Treatment of Infectious Bursitis

This study is currently recruiting participants.
Verified June 2011 by University Hospital, Geneva
Sponsor:
Information provided by:
University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT01406652
First received: June 27, 2011
Last updated: July 29, 2011
Last verified: June 2011

June 27, 2011
July 29, 2011
May 2011
June 2014   (final data collection date for primary outcome measure)
Reduction of total costs associated with one-stage treatement of septic bursitis [ Time Frame: Patients will be followed-up during hospital stay and during 2 months after discharge ] [ Designated as safety issue: No ]

Onestage bursectomy is associated with significantly reduced costs of overall treatement of septic bursitis compared to a two-stage approach.

The cost reduction concerns probably all strata of cost evaluation: surgery and anesthesiology costs, nursing costs, costs related to postoperative follow-ups, medication use, and absence from work

Same as current
Complete list of historical versions of study NCT01406652 on ClinicalTrials.gov Archive Site
Equivalence of one-stage bursectomy compared to two-stage bursectomy in terms of recurrence [ Time Frame: Patients will be followed-up during hospital stay and during 2 months after discharge ] [ Designated as safety issue: Yes ]
The one-stage approach does not only reduce costs, but harbors equally remission/cure rates of septic bursitis than the two-stage approach.
Same as current
Not Provided
Not Provided
 
Optimisation of the Treatment of Infectious Bursitis
One-stage Versus Two-stage Surgical Treatement of Infectious Bursitis

Th study investigates prospectively the cost-savings related to a one-stage bursectomy (debridement, drainage and closure at the same time) versus two-stage bursectomy (debridement, left open and closure at a second time) of severe bursitis among hospitalized patients for surgical treatment of septic bursitis.

We suppose that the one-stage bursectomy reveals similar recurrence rates but is associated with a significant shortening of hospital stay, consumption of resources and increased patient satisfaction.

Start as single center interventional study at Geneva University Hospitals Study open for additional centres (electronic CRF) Funding on 24.6.2011 (50,000 Swiss Francs). Further demand for funding ongoing.

Spetic bursitis of knee and elbows, for which the patients are hospitalised (a substantial part of patient with failure of conservative treatement) Randomisation 1:1 (one-stage vs. two-stage).

Duration of concomitant postsurgical antibiotic therapy fixed to 7 days Exclusion of severely immuno-depressed patients.

Assessment of all costs of inpatient treatement and outpatient follow-up of included cases.

Interim analysis after ca. 100 cases planified

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Olecranon Bursitis
  • Patellar Bursitis
Procedure: Two-stage bursectomy
Debridement, drainage, and secondary closure of septic bursitis during two surgical interventions
Other Name: There are no "other names"
Experimental: One-stage bursectomy
Bursectomy with debridement and primary closure of the wound during one surgical intervention
Intervention: Procedure: Two-stage bursectomy
Perez C, Huttner A, Assal M, Bernard L, Lew D, Hoffmeyer P, Uçkay I. Infectious olecranon and patellar bursitis: short-course adjuvant antibiotic therapy is not a risk factor for recurrence in adult hospitalized patients. J Antimicrob Chemother. 2010 May;65(5):1008-14. doi: 10.1093/jac/dkq043. Epub 2010 Mar 1.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
240
June 2014
June 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Age >18 years
  2. Hospitalized for bursectomy for septic bursitis

Exclusion Criteria:

  1. Bacteraemic diseases
  2. Presence of another concomitant infection requiring antibiotics
  3. Presence of osteosynthesis material beneath the bursitis
  4. Spetic bursitis outside of the elbow or the knee
  5. Severe immune suppression (transplantation, HIV with CD4 count <200 cells/mm3, immune suppressive treatement with aequivalence of more than 15 mg of prednisone daily ).
  6. Recurrent septic bursitis episodes
Both
18 Years and older
No
Contact: Ilker UCKAY, MD +41 22 372 33 11 ilker.uckay@hcuge.ch
Contact: Cedric PEREZ, MD +41 22 372 33 11 cedric.perez@hcuge.ch
Switzerland
 
NCT01406652
11-016 (NAC 11-004)
Yes
Ilker UCKAY, MD, Geneva University Hospitals
University Hospital, Geneva
Not Provided
Principal Investigator: Ilker UCKAY, MD University Hospital, Geneva
University Hospital, Geneva
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP