Clinical trial NCT01406652: Optimisation of the Treatment of Infectious Bursitis
Official title: One-stage Versus Two-stage Surgical Treatment of Infectious Bursitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Olecranon Bursitis
Patellar Bursitis
Keywords: septic bursitis
bursectomy
primary closure
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2011-08-01
Enrollment: 224
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Randomization 1:1 with two arms: One versus two-stage bursectomy.
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility 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. Septic bursitis outside of the elbow or the knee
5. 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 ).
6. Recurrent septic bursitis episodes

Primary outcomes:
measure: Overall Costs of the Combined Surgical and Medical Treatment
timeFrame: 2 months
Secondary outcomes:
measure: Number of Participants With Post-surgical Wound Dehiscence
timeFrame: 2 months
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Geneva University Hospitals
Study officials:
affiliation: University Hospital, Geneva
name: Ilker UCKAY, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.