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Optimisation of the Treatment of Infectious Bursitis

Primary Purpose

Olecranon Bursitis, Patellar Bursitis

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Two-stage bursectomy
Sponsored by
University Hospital, Geneva
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Olecranon Bursitis focused on measuring septic bursitis, bursectomy, primary closure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Geneva University Hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

One-stage bursectomy

Two-stage bursectomy

Arm Description

Bursectomy with debridement and primary closure of the wound during one surgical intervention

Bursectomy with debridement and left open. Wound closure in a second step and in a second surgery.

Outcomes

Primary Outcome Measures

Overall Costs of the Combined Surgical and Medical Treatment
The overall costs are of primary interest in the study protocol.

Secondary Outcome Measures

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.

Full Information

First Posted
June 27, 2011
Last Updated
November 27, 2019
Sponsor
University Hospital, Geneva
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1. Study Identification

Unique Protocol Identification Number
NCT01406652
Brief Title
Optimisation of the Treatment of Infectious Bursitis
Official Title
One-stage Versus Two-stage Surgical Treatment of Infectious Bursitis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Geneva

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Olecranon Bursitis, Patellar Bursitis
Keywords
septic bursitis, bursectomy, primary closure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
Randomization 1:1 with two arms: One versus two-stage bursectomy.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
224 (Actual)

8. Arms, Groups, and Interventions

Arm Title
One-stage bursectomy
Arm Type
Active Comparator
Arm Description
Bursectomy with debridement and primary closure of the wound during one surgical intervention
Arm Title
Two-stage bursectomy
Arm Type
Experimental
Arm Description
Bursectomy with debridement and left open. Wound closure in a second step and in a second surgery.
Intervention Type
Procedure
Intervention Name(s)
Two-stage bursectomy
Other Intervention Name(s)
There are no "other names"
Intervention Description
Debridement, drainage, and secondary closure of septic bursitis during two surgical interventions
Primary Outcome Measure Information:
Title
Overall Costs of the Combined Surgical and Medical Treatment
Description
The overall costs are of primary interest in the study protocol.
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Number of Participants With Post-surgical Wound Dehiscence
Description
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.
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ilker UCKAY, MD
Organizational Affiliation
University Hospital, Geneva
Official's Role
Principal Investigator
Facility Information:
Facility Name
Geneva University Hospitals
City
Geneva
ZIP/Postal Code
1211
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20197288
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.
Results Reference
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PubMed Identifier
28602435
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.
Results Reference
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PubMed Identifier
26814924
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.
Results Reference
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Optimisation of the Treatment of Infectious Bursitis

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