Optimisation of the Treatment of Infectious Bursitis

November 27, 2019 updated by: Ilker Uckay, University Hospital, Geneva

One-stage Versus Two-stage Surgical Treatment of Infectious Bursitis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

224

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Geneva, Switzerland, 1211
        • Geneva University Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • There are no "other names"

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Costs of the Combined Surgical and Medical Treatment
Time Frame: 2 months
The overall costs are of primary interest in the study protocol.
2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Geneva

Investigators

  • Principal Investigator: Ilker Uçkay, MD, University Hospital, Geneva

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

June 27, 2011

First Submitted That Met QC Criteria

July 29, 2011

First Posted (Estimate)

August 1, 2011

Study Record Updates

Last Update Posted (Actual)

December 2, 2019

Last Update Submitted That Met QC Criteria

November 27, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-016 (NAC 11-004)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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