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Optimisation of the Treatment of Infectious Bursitis

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ClinicalTrials.gov Identifier: NCT01406652
Recruitment Status : Completed
First Posted : August 1, 2011
Results First Posted : November 5, 2019
Last Update Posted : November 5, 2019
Sponsor:
Information provided by (Responsible Party):
Ilker Uckay, University Hospital, Geneva

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.


Condition or disease Intervention/treatment Phase
Olecranon Bursitis Patellar Bursitis Procedure: Two-stage bursectomy Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 224 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: Randomization 1:1 with two arms: One versus two-stage bursectomy.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: One-stage Versus Two-stage Surgical Treatment of Infectious Bursitis
Study Start Date : May 2011
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bursitis

Arm Intervention/treatment
Active Comparator: One-stage bursectomy
Bursectomy with debridement and primary closure of the wound during one surgical intervention
Procedure: Two-stage bursectomy
Debridement, drainage, and secondary closure of septic bursitis during two surgical interventions
Other Name: There are no "other names"

Experimental: Two-stage bursectomy
Bursectomy with debridement and left open. Wound closure in a second step and in a second surgery.
Procedure: Two-stage bursectomy
Debridement, drainage, and secondary closure of septic bursitis during two surgical interventions
Other Name: There are no "other names"




Primary Outcome Measures :
  1. Overall Costs of the Combined Surgical and Medical Treatment [ Time Frame: 2 months ]
    The overall costs are of primary interest in the study protocol.


Secondary Outcome Measures :
  1. Number of Participants With Post-surgical Wound Dehiscence [ Time Frame: 2 months ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01406652


Locations
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Switzerland
Geneva University Hospitals
Geneva, Switzerland, 1211
Sponsors and Collaborators
University Hospital, Geneva
Investigators
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Principal Investigator: Ilker UCKAY, MD University Hospital, Geneva

Publications:
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Responsible Party: Ilker Uckay, PD Dr. med, MD, Attending, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT01406652     History of Changes
Other Study ID Numbers: 11-016 (NAC 11-004)
First Posted: August 1, 2011    Key Record Dates
Results First Posted: November 5, 2019
Last Update Posted: November 5, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Ilker Uckay, University Hospital, Geneva:
septic bursitis
bursectomy
primary closure
Additional relevant MeSH terms:
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Bursitis
Joint Diseases
Musculoskeletal Diseases