Optimisation of the Treatment of Infectious Bursitis

Study Overview
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Brief Summary
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The 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.

Detailed Description
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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. Septic bursitis of knee and elbows, for which the patients are hospitalised (a substantial part of patient with failure of conservative treatment) 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 treatment and outpatient follow-up of included cases. Interim analysis after ca. 100 cases planified.

Official Title
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One-stage Versus Two-stage Surgical Treatment of Infectious Bursitis

Conditions
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Olecranon Bursitis, Patellar Bursitis

Intervention / Treatment
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* Procedure: Two-stage bursectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >18 years Hospitalized for bursectomy for septic bursitis Exclusion Criteria: Bacteraemic diseases Presence of another concomitant infection requiring antibiotics Presence of osteosynthesis material beneath the bursitis Septic bursitis outside of the elbow or the knee Severe immune suppression (transplantation, HIV with Cluster of Differentiation cell count <200 cells/mm3, immune suppressive treatment with equivalence of more than 15 mg of prednisone daily ). Recurrent septic bursitis episodes

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: Randomization 1:1 with two arms: One versus two-stage bursectomy.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: One-stage bursectomy<br>Bursectomy with debridement and primary closure of the wound during one surgical intervention | Procedure: Two-stage bursectomy<br>* Debridement, drainage, and secondary closure of septic bursitis during two surgical interventions<br>* Other names: There are no other names;|
| Experimental: Two-stage bursectomy<br>Bursectomy with debridement and left open. Wound closure in a second step and in a second surgery. | Procedure: Two-stage bursectomy<br>* Debridement, drainage, and secondary closure of septic bursitis during two surgical interventions<br>* Other names: There are no other names;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Costs of the Combined Surgical and Medical Treatment | The overall costs are of primary interest in the study protocol. | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Post-surgical Wound Dehiscence | We assess clinical failures of bursectomy for bursitis. As recurrences are associated with wound dehiscence, we evaluate the dehiscence a the most important parameter for Failure. Of course, dehiscence can also occur without recurrent infection, but this is also considered as failure. | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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septic bursitis, bursectomy, primary closure