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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
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: One-stage Versus Two-stage Surgical Treatement of Infectious Bursitis

Resource links provided by NLM:

MedlinePlus related topics: Bursitis
U.S. FDA Resources

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 ] [ 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



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 ] [ 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.


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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01406652

Contacts
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

Locations
Switzerland
Geneva University Hospitals Recruiting
Geneva, Switzerland, 1211
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    
Principal Investigator: Ilker UCKAY, MD            
Sponsors and Collaborators
University Hospital, Geneva
Investigators
Principal Investigator: Ilker UCKAY, MD University Hospital, Geneva
  More Information

Publications:

Responsible Party: Ilker UCKAY, MD, Geneva University Hospitals
ClinicalTrials.gov 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
Health Authority: Switzerland: Ethikkommission

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

Additional relevant MeSH terms:
Bursitis
Joint Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on May 19, 2013