Trial Outcomes & Findings for S. Aureus Screening and Decolonization (NCT NCT02182115)
NCT ID: NCT02182115
Last Updated: 2019-11-05
Results Overview
Participants with no SA post-treatment, proportion (%) of participants in each study arm that had no SA detected on the post-treatment cultures from the 4 body sites sampled with swab cultures.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
110 participants
Primary outcome timeframe
Immediately prior to surgery patients are swabbed again at the 4 body sites to see if SA is present or not.
Results posted on
2019-11-05
Participant Flow
Participant milestones
| Measure |
Standard of Care
Surgeon's routine for preoperative showering.
standard of care: Surgeon's instructions may include advising patients to use an antiseptic soap prior to surgery.
|
Antiseptic Bundle
Patients to use study bundle for 5 days prior to scheduled surgery with the following medications to use at home.
1. Chlorhexidine gluconate soap applied for bathing daily.
2. Chlorhexidine gluconate mouthrinse used to rinse mouth twice daily.
3. Nasal mupirocin to applied inside nostrils twice daily.
|
|---|---|---|
|
Overall Study
STARTED
|
53
|
57
|
|
Overall Study
COMPLETED
|
53
|
57
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
S. Aureus Screening and Decolonization
Baseline characteristics by cohort
| Measure |
Standard of Care
n=53 Participants
Surgeon's routine for preoperative showering. Surgeon's instructions may include advising patients to use an antiseptic soap prior to surgery.
Other Name: Follow surgeon's instructions for pre-operative bathing.
|
Antiseptic Bundle
n=57 Participants
Patients to use study bundle for 5 days prior to scheduled surgery with the following medications to use at home.
Chlorhexidine gluconate soap applied for bathing daily. Chlorhexidine gluconate mouthrinse used to rinse mouth twice daily. Nasal mupirocin to applied inside nostrils twice daily.
|
Total
n=110 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
41 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Age, Continuous
|
52.5 years
STANDARD_DEVIATION 13.1 • n=5 Participants
|
58.8 years
STANDARD_DEVIATION 13.3 • n=7 Participants
|
55.8 years
STANDARD_DEVIATION 13.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
44 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other racial/ethnic groups
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown or incomplete racial/ethnic group
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Staphylococcus aureus carriage
|
53 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
110 Participants
n=5 Participants
|
|
STAPHYLOCOCCUS AUREUS TYPE
Methicillin sensitive Staphylococcus aureus (MSSA)
|
48 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
99 Participants
n=5 Participants
|
|
STAPHYLOCOCCUS AUREUS TYPE
Methicillin resistant Staphylococcus aureus (MRSA)
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Immediately prior to surgery patients are swabbed again at the 4 body sites to see if SA is present or not.Participants with no SA post-treatment, proportion (%) of participants in each study arm that had no SA detected on the post-treatment cultures from the 4 body sites sampled with swab cultures.
Outcome measures
| Measure |
Standard of Care
n=53 Participants
Surgeon's routine for preoperative showering.
standard of care: Surgeon's instructions may include advising patients to use an antiseptic soap prior to surgery.
|
Antiseptic Bundle
n=57 Participants
Patients to use study bundle for 5 days prior to scheduled surgery with the following medications to use at home.
1. Chlorhexidine gluconate soap applied for bathing daily.
2. Chlorhexidine gluconate mouthrinse used to rinse mouth twice daily.
3. Nasal mupirocin to applied inside nostrils twice daily.
antiseptic bundle: 1. Chlorhexidine gluconate liquid soap for bathing daily. 2. Chlorhexidine gluconate mouthrinse to use twice daily. 3. Nasal mupirocin to apply twice daily.
|
|---|---|---|
|
Eradication of Staphylococcus Aureus (SA) Carriage at All 4 Body Sites Tested.
|
13 Participants
|
41 Participants
|
Adverse Events
Standard of Care
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
Antiseptic Bundle
Serious events: 10 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Standard of Care
n=53 participants at risk
Used surgeon recommended soap for two pre-op showers, one the night before and one the morning of surgery.
|
Antiseptic Bundle
n=57 participants at risk
Used three drug antiseptic bundle for 5 days.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
non-healing wound
|
1.9%
1/53 • Number of events 1 • 2 years
|
0.00%
0/57 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
1.9%
1/53 • Number of events 1 • 2 years
|
1.8%
1/57 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary embolus
|
1.9%
1/53 • Number of events 1 • 2 years
|
0.00%
0/57 • 2 years
|
|
Nervous system disorders
radial nerve palsy
|
1.9%
1/53 • Number of events 1 • 2 years
|
0.00%
0/57 • 2 years
|
|
Blood and lymphatic system disorders
DVT
|
1.9%
1/53 • Number of events 1 • 2 years
|
0.00%
0/57 • 2 years
|
|
Renal and urinary disorders
UTI
|
1.9%
1/53 • Number of events 1 • 2 years
|
1.8%
1/57 • Number of events 1 • 2 years
|
|
Blood and lymphatic system disorders
bacteremia
|
1.9%
1/53 • Number of events 1 • 2 years
|
0.00%
0/57 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
lung collapse
|
0.00%
0/53 • 2 years
|
1.8%
1/57 • Number of events 1 • 2 years
|
|
Nervous system disorders
subdural hematoma
|
0.00%
0/53 • 2 years
|
1.8%
1/57 • Number of events 1 • 2 years
|
|
Nervous system disorders
post-op pseudomeningocele
|
0.00%
0/53 • 2 years
|
1.8%
1/57 • Number of events 1 • 2 years
|
|
Musculoskeletal and connective tissue disorders
thoracic spine fracture post-op
|
0.00%
0/53 • 2 years
|
1.8%
1/57 • Number of events 1 • 2 years
|
|
Musculoskeletal and connective tissue disorders
uncontrolled post-operative pain
|
0.00%
0/53 • 2 years
|
1.8%
1/57 • Number of events 1 • 2 years
|
|
Blood and lymphatic system disorders
Chyle leak
|
0.00%
0/53 • 2 years
|
1.8%
1/57 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
swallowing difficulties
|
0.00%
0/53 • 2 years
|
1.8%
1/57 • Number of events 1 • 2 years
|
|
Skin and subcutaneous tissue disorders
cervical seroma
|
0.00%
0/53 • 2 years
|
1.8%
1/57 • Number of events 1 • 2 years
|
|
Renal and urinary disorders
gross hematuria
|
0.00%
0/53 • 2 years
|
3.5%
2/57 • Number of events 2 • 2 years
|
|
Gastrointestinal disorders
Clostridium difficile diarrhea
|
0.00%
0/53 • 2 years
|
1.8%
1/57 • Number of events 1 • 2 years
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place