Trial Outcomes & Findings for Optimisation of the Treatment of Infectious Bursitis (NCT NCT01406652)
NCT ID: NCT01406652
Last Updated: 2019-12-02
Results Overview
The overall costs are of primary interest in the study protocol.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
224 participants
Primary outcome timeframe
2 months
Results posted on
2019-12-02
Participant Flow
See below
Participant milestones
| Measure |
One-stage Bursectomy
79 patients undergo surgical bursectomy and wound closure within the same Operation.
|
Two-stage Bursectomy
85 patients have a two-stage Approach. First, they undergo surgical bursectomy with the wound left open. In a second step 3-4 days later, they are re-operated for wound closure.
|
|---|---|---|
|
Overall Study
STARTED
|
109
|
115
|
|
Overall Study
COMPLETED
|
89
|
95
|
|
Overall Study
NOT COMPLETED
|
20
|
20
|
Reasons for withdrawal
| Measure |
One-stage Bursectomy
79 patients undergo surgical bursectomy and wound closure within the same Operation.
|
Two-stage Bursectomy
85 patients have a two-stage Approach. First, they undergo surgical bursectomy with the wound left open. In a second step 3-4 days later, they are re-operated for wound closure.
|
|---|---|---|
|
Overall Study
Lost-to-follow-up
|
3
|
4
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
|
Overall Study
Insufficient follow-up
|
5
|
4
|
|
Overall Study
Infection not sure
|
10
|
10
|
Baseline Characteristics
Optimisation of the Treatment of Infectious Bursitis
Baseline characteristics by cohort
| Measure |
One-stage Bursectomy
n=79 Participants
Bursectomy with debridement and primary closure of the wound during one surgical intervention
|
Two-stage Bursectomy
n=85 Participants
Two-stage bursectomy: Debridement, drainage, and secondary closure of septic bursitis during two surgical interventions
|
Total
n=164 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Region of Enrollment
Switzerland
|
79 participants
n=39 Participants
|
85 participants
n=41 Participants
|
164 participants
n=35 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
70 Participants
n=39 Participants
|
80 Participants
n=41 Participants
|
150 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
14 Participants
n=35 Participants
|
|
Age, Continuous
|
53 years
n=39 Participants
|
51 years
n=41 Participants
|
52 years
n=35 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=39 Participants
|
11 Participants
n=41 Participants
|
28 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
62 Participants
n=39 Participants
|
74 Participants
n=41 Participants
|
136 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
79 Participants
n=39 Participants
|
85 Participants
n=41 Participants
|
164 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: 2 monthsPopulation: The overall costs (Swiss francs; CHF) are of primary interest in the study protocol
The overall costs are of primary interest in the study protocol.
Outcome measures
| Measure |
One-stage Bursectomy
n=79 Participants
Total costs in Swiss francs of the one-stage bursectomy approach and associated treatment.
|
Two-stage Bursectomy
n=85 Participants
Total costs in Swiss francs of the one-stage bursectomy approach and associated treatment.
|
|---|---|---|
|
Overall Costs of the Combined Surgical and Medical Treatment
|
6881 Swiss Francs
Interval 4587.0 to 8254.0
|
11178 Swiss Francs
Interval 9231.0 to 12498.0
|
SECONDARY outcome
Timeframe: 2 monthsWe 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.
Outcome measures
| Measure |
One-stage Bursectomy
n=79 Participants
Total costs in Swiss francs of the one-stage bursectomy approach and associated treatment.
|
Two-stage Bursectomy
n=85 Participants
Total costs in Swiss francs of the one-stage bursectomy approach and associated treatment.
|
|---|---|---|
|
Number of Participants With Post-surgical Wound Dehiscence
|
2 participants
|
10 participants
|
Adverse Events
One-versus Bursectomy
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Two-stage Busectomy
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
One-versus Bursectomy
n=79 participants at risk
Bursectomy and surgical wound closure during the same surgery
|
Two-stage Busectomy
n=85 participants at risk
Bursectomy during the first surgery, followed by a surgical closure in a second step.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Handicap
|
17.7%
14/79 • Number of events 14 • 2 months post surgical follow-up
|
17.6%
15/85 • Number of events 15 • 2 months post surgical follow-up
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place