Optimisation of the Treatment of Infectious Bursitis
|ClinicalTrials.gov Identifier: NCT01406652|
Recruitment Status : Unknown
Verified June 2011 by University Hospital, Geneva.
Recruitment status was: Recruiting
First Posted : August 1, 2011
Last Update Posted : August 1, 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 or disease||Intervention/treatment||Phase|
|Olecranon Bursitis Patellar Bursitis||Procedure: Two-stage bursectomy||Phase 3|
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||240 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||One-stage Versus Two-stage Surgical Treatement of Infectious Bursitis|
|Study Start Date :||May 2011|
|Estimated Primary Completion Date :||June 2014|
|Estimated Study Completion Date :||June 2014|
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"
- 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
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01406652
|Contact: Ilker UCKAY, MD||+41 22 372 33 firstname.lastname@example.org|
|Contact: Cedric PEREZ, MD||+41 22 372 33 email@example.com|
|Geneva University Hospitals||Recruiting|
|Geneva, Switzerland, 1211|
|Contact: Ilker UCKAY, MD +41 22 372 33 11 firstname.lastname@example.org|
|Contact: Cedric PEREZ, MD +41 22 372 33 11 email@example.com|
|Principal Investigator: Ilker UCKAY, MD|
|Principal Investigator:||Ilker UCKAY, MD||University Hospital, Geneva|