Completed

NCT Number: NCT01406652

Optimisation of the 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.

Completed

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Key information

Conditions

Olecranon Bursitis Patellar Bursitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Geneva University Hospitals

Geneva, 1211, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Two-stage bursectomy

Procedure

Debridement, drainage, and secondary closure of septic bursitis during two surgical interventions

Other names: There are no "other names"

Primary outcomes

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 outcomes

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.

Sponsors and collaborators

Lead sponsor

University Hospital, Geneva

Other

Registry information

Official study title

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

Important dates

Study start: 2011
Primary completion: 2016
Study completion: 2016
First posted: Aug 1, 2011
Registry last updated: Dec 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.