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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| One-stage bursectomy | Active Comparator | Bursectomy with debridement and primary closure of the wound during one surgical intervention |
|
| Two-stage bursectomy | Experimental | Bursectomy with debridement and left open. Wound closure in a second step and in a second surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Two-stage bursectomy | Procedure | Debridement, drainage, and secondary closure of septic bursitis during two surgical interventions |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ilker UCKAY, MD | University Hospital, Geneva | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Geneva University Hospitals | Geneva | 1211 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20197288 | Background | Perez C, Huttner A, Assal M, Bernard L, Lew D, Hoffmeyer P, Uckay I. Infectious olecranon and patellar bursitis: short-course adjuvant antibiotic therapy is not a risk factor for recurrence in adult hospitalized patients. J Antimicrob Chemother. 2010 May;65(5):1008-14. doi: 10.1093/jac/dkq043. Epub 2010 Mar 1. | |
| 28602435 | Background |
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See below
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| ID | Title | Description |
|---|---|---|
| FG000 | One-stage Bursectomy | 79 patients undergo surgical bursectomy and wound closure within the same Operation. |
| FG001 | Two-stage Bursectomy | 85 patients have a two-stage Approach. First, they undergo surgical bursectomy with the wound left open. In a second step 3-4 days later, they are re-operated for wound closure. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | One-stage Bursectomy | Bursectomy with debridement and primary closure of the wound during one surgical intervention |
| BG001 | Two-stage Bursectomy | Two-stage bursectomy: Debridement, drainage, and secondary closure of septic bursitis during two surgical interventions |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Costs of the Combined Surgical and Medical Treatment | The overall costs are of primary interest in the study protocol. | The overall costs (Swiss francs; CHF) are of primary interest in the study protocol | Posted | Median | Inter-Quartile Range | Swiss Francs | 2 months |
|
2 months post surgical follow-up
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | One-versus Bursectomy | Bursectomy and surgical wound closure during the same surgery |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Handicap | Musculoskeletal and connective tissue disorders | Systematic Assessment | Persistant postsurgical pain |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr.med Ilker Uçkay | Geneva University Hospitals | +412237123311 | ilker.uckay@hcuge.ch |
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Randomization 1:1 with two arms: One versus two-stage bursectomy.
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|
| Uckay I, von Dach E, Perez C, Agostinho A, Garnerin P, Lipsky BA, Hoffmeyer P, Pittet D. One- vs 2-Stage Bursectomy for Septic Olecranon and Prepatellar Bursitis: A Prospective Randomized Trial. Mayo Clin Proc. 2017 Jul;92(7):1061-1069. doi: 10.1016/j.mayocp.2017.03.011. Epub 2017 Jun 8. |
| 26814924 | Background | Baumbach SF, Wyen H, Perez C, Kanz KG, Uckay I. Evaluation of current treatment regimens for prepatellar and olecranon bursitis in Switzerland. Eur J Trauma Emerg Surg. 2013 Feb;39(1):65-72. doi: 10.1007/s00068-012-0236-4. Epub 2012 Nov 8. |
| Insufficient follow-up |
|
| Infection not sure |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | 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. | Posted | Number | participants | 2 months |
|
|
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| 0 |
| 79 |
| 0 |
| 79 |
| 14 |
| 79 |
| EG001 | Two-stage Busectomy | Bursectomy during the first surgery, followed by a surgical closure in a second step. | 0 | 85 | 0 | 85 | 15 | 85 |
|
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