Olecranon Bursitis, Patellar Bursitis
Conditions
Keywords
septic bursitis, bursectomy, primary closure
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.
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.
Interventions
PROCEDURETwo-stage bursectomy
Debridement, drainage, and secondary closure of septic bursitis during two surgical interventions
Sponsors
University Hospital, Geneva
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomization 1:1 with two arms: One versus two-stage bursectomy.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Costs of the Combined Surgical and Medical Treatment | 2 months | The overall costs are of primary interest in the study protocol. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Post-surgical Wound Dehiscence | 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. |
Countries
Switzerland
Participant flow
Pre-assignment details
See below
Participants by arm
| Arm | Count |
|---|---|
| One-stage Bursectomy Bursectomy with debridement and primary closure of the wound during one surgical intervention | 79 |
| Two-stage Bursectomy Two-stage bursectomy: Debridement, drainage, and secondary closure of septic bursitis during two surgical interventions | 85 |
| Total | 164 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Infection not sure | 10 | 10 |
| Overall Study | Insufficient follow-up | 5 | 4 |
| Overall Study | Lost-to-follow-up | 3 | 4 |
| Overall Study | Withdrawal by Subject | 2 | 2 |
Baseline characteristics
| Characteristic | Two-stage Bursectomy | Total | One-stage Bursectomy |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 14 Participants | 9 Participants |
| Age, Categorical Between 18 and 65 years | 80 Participants | 150 Participants | 70 Participants |
| Age, Continuous | 51 years | 52 years | 53 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 85 Participants | 164 Participants | 79 Participants |
| Region of Enrollment Switzerland | 85 participants | 164 participants | 79 participants |
| Sex: Female, Male Female | 11 Participants | 28 Participants | 17 Participants |
| Sex: Female, Male Male | 74 Participants | 136 Participants | 62 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 79 | 0 / 85 |
| other Total, other adverse events | 14 / 79 | 15 / 85 |
| serious Total, serious adverse events | 0 / 79 | 0 / 85 |
Outcome results
Primary
Overall Costs of the Combined Surgical and Medical Treatment
The overall costs are of primary interest in the study protocol.
Time frame: 2 months
Population: The overall costs (Swiss francs; CHF) are of primary interest in the study protocol
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| One-stage Bursectomy | Overall Costs of the Combined Surgical and Medical Treatment | 6881 Swiss Francs |
| Two-stage Bursectomy | Overall Costs of the Combined Surgical and Medical Treatment | 11178 Swiss Francs |
Secondary
Number of Participants With Post-surgical Wound Dehiscence
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.
Time frame: 2 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| One-stage Bursectomy | Number of Participants With Post-surgical Wound Dehiscence | 2 participants |
| Two-stage Bursectomy | Number of Participants With Post-surgical Wound Dehiscence | 10 participants |