Optimisation of the Treatment of Infectious Bursitis

University Hospitals (UH)

Status: Completed

Conditions: Patellar Bursitis; Olecranon Bursitis

Treatments: Procedure: Two-stage bursectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT01406652

11-016 (NAC 11-004)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 224 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

---

224 participants in 2 patient groups

One-stage bursectomy

Active Comparator group

Description:

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

Treatment:

Procedure: Two-stage bursectomy

Two-stage bursectomy

Experimental group

Description:

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

Treatment:

Procedure: Two-stage bursectomy