Clinical Trial: Optimisation of the Treatment of Infectious Bursitis

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: One-stage Versus Two-stage Surgical Treatement of Infectious Bursitis

Brief Summary:

Th 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 Summary:

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.

Spetic bursitis of knee and elbows, for which the patients are hospitalised (a substantial part of patient with failure of conservative treatement) 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 treatement and outpatient follow-up of included cases.

Interim analysis after ca. 100 cases planified


Sponsor: University Hospital, Geneva

Current Primary Outcome: Reduction of total costs associated with one-stage treatement of septic bursitis [ Time Frame: Patients will be followed-up during hospital stay and during 2 months after discharge ]

Onestage bursectomy is associated with significantly reduced costs of overall treatement of septic bursitis compared to a two-stage approach.

The cost reduction concerns probably all strata of cost evaluation: surgery and anesthesiology costs, nursing costs, costs related to postoperative follow-ups, medication use, and absence from work



Original Primary Outcome: Same as current

Current Secondary Outcome: Equivalence of one-stage bursectomy compared to two-stage bursectomy in terms of recurrence [ Time Frame: Patients will be followed-up during hospital stay and during 2 months after discharge ]

The one-stage approach does not only reduce costs, but harbors equally remission/cure rates of septic bursitis than the two-stage approach.


Original Secondary Outcome: Same as current

Information By: University Hospital, Geneva

Dates:
Date Received: June 27, 2011
Date Started: May 2011
Date Completion: June 2014
Last Updated: July 29, 2011
Last Verified: June 2011