Optimisation of the Treatment of Infectious Bursitis
Recruitment status was: Recruiting
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.
Procedure: Two-stage bursectomy
|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|
- 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
- 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.
|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)|
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"
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01406652
|Geneva University Hospitals|
|Geneva, Switzerland, 1211|
|Principal Investigator:||Ilker UCKAY, MD||University Hospital, Geneva|