Olecranon Bursitis Clinical Trial
Official title:
One-stage Versus Two-stage Surgical Treatment of Infectious Bursitis
| NCT number | NCT01406652 |
| Other study ID # | 11-016 (NAC 11-004) |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | May 2011 |
| Est. completion date | July 2016 |
| Verified date | November 2019 |
| Source | University Hospital, Geneva |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 224 |
| Est. completion date | July 2016 |
| Est. primary completion date | July 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Switzerland | Geneva University Hospitals | Geneva |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Geneva |
Switzerland,
Baumbach SF, Wyen H, Perez C, Kanz KG, Uçkay 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. — View Citation
Perez C, Huttner A, Assal M, Bernard L, Lew D, Hoffmeyer P, Uçkay 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. — View Citation
Uçkay 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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Overall Costs of the Combined Surgical and Medical Treatment | The overall costs are of primary interest in the study protocol. | 2 months | |
| 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. | 2 months |