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Optimisation of the Treatment of Infectious Bursitis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2011 by University Hospital, Geneva.
Recruitment status was:  Recruiting
Information provided by:
University Hospital, Geneva Identifier:
First received: June 27, 2011
Last updated: July 29, 2011
Last verified: June 2011

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.

Condition Intervention Phase
Olecranon Bursitis Patellar Bursitis Procedure: Two-stage bursectomy Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: One-stage Versus Two-stage Surgical Treatement of Infectious Bursitis

Resource links provided by NLM:

Further study details as provided by University Hospital, Geneva:

Primary Outcome Measures:
  • 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 ]

    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

Secondary Outcome Measures:
  • 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 ]
    The one-stage approach does not only reduce costs, but harbors equally remission/cure rates of septic bursitis than the two-stage approach.

Estimated Enrollment: 240
Study Start Date: May 2011
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: One-stage bursectomy
Bursectomy with debridement and primary closure of the wound during one surgical intervention
Procedure: Two-stage bursectomy
Debridement, drainage, and secondary closure of septic bursitis during two surgical interventions
Other Name: There are no "other names"

Detailed Description:

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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01406652

Contact: Ilker UCKAY, MD +41 22 372 33 11
Contact: Cedric PEREZ, MD +41 22 372 33 11

Geneva University Hospitals Recruiting
Geneva, Switzerland, 1211
Contact: Ilker UCKAY, MD    +41 22 372 33 11   
Contact: Cedric PEREZ, MD    +41 22 372 33 11   
Principal Investigator: Ilker UCKAY, MD         
Sponsors and Collaborators
University Hospital, Geneva
Principal Investigator: Ilker UCKAY, MD University Hospital, Geneva
  More Information

Responsible Party: Ilker UCKAY, MD, Geneva University Hospitals Identifier: NCT01406652     History of Changes
Other Study ID Numbers: 11-016 (NAC 11-004)
Study First Received: June 27, 2011
Last Updated: July 29, 2011

Keywords provided by University Hospital, Geneva:
septic bursitis
primary closure

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases processed this record on September 21, 2017