Trial Outcomes & Findings for Reducing Perioperative S. Aureus Transmission (NCT NCT03638947)
NCT ID: NCT03638947
Last Updated: 2022-07-01
Results Overview
Compare the number of S. aureus transmission events for patients who receive the standard presurgical preparation verses patients who receive decolonization interventions.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
236 participants
Primary outcome timeframe
Up to 180 days following surgery
Results posted on
2022-07-01
Participant Flow
Participant milestones
| Measure |
Standard of Care
Patient will receive by mail a kit containing swab for the nares, armpit and groin.
|
Swab Kit Plus Povidone-iodine Soap
Patient will receive by mail a kit containing swab for the nares, armpit and groin. In addition the patient will receive decolonization treatment including povidone-iodine soap for presurgical cleansing two days prior to surgery.
Swab and decolonization using povidone-iodine cleansing: Patient in this group will receive improved environmental cleaning and undergo surveillance using swabs and decolonization cleansing.
|
|---|---|---|
|
Overall Study
STARTED
|
130
|
106
|
|
Overall Study
COMPLETED
|
130
|
106
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Standard of Care
n=130 Participants
Patient will receive by mail a kit containing swab for the nares, armpit and groin.
|
Swab Kit Plus Povidone-iodine Soap
n=106 Participants
Patient will receive by mail a kit containing swab for the nares, armpit and groin. In addition the patient will receive decolonization treatment including povidone-iodine soap for presurgical cleansing two days prior to surgery.
Swab and decolonization using povidone-iodine cleansing: Patient in this group will receive improved environmental cleaning and undergo surveillance using swabs and decolonization cleansing.
|
Total
n=236 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=130 Participants
|
1 Participants
n=106 Participants
|
1 Participants
n=236 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
88 Participants
n=130 Participants
|
60 Participants
n=106 Participants
|
148 Participants
n=236 Participants
|
|
Age, Categorical
>=65 years
|
42 Participants
n=130 Participants
|
45 Participants
n=106 Participants
|
87 Participants
n=236 Participants
|
|
Sex: Female, Male
Female
|
112 Participants
n=130 Participants
|
43 Participants
n=106 Participants
|
155 Participants
n=236 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=130 Participants
|
63 Participants
n=106 Participants
|
81 Participants
n=236 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
130 participants
n=130 Participants
|
106 participants
n=106 Participants
|
236 participants
n=236 Participants
|
PRIMARY outcome
Timeframe: Up to 180 days following surgeryCompare the number of S. aureus transmission events for patients who receive the standard presurgical preparation verses patients who receive decolonization interventions.
Outcome measures
| Measure |
Standard of Care
n=130 Participants
Patient will receive by mail a kit containing swab for the nares, armpit and groin.
|
Swab Kit Plus Povidone-iodine Soap
n=106 Participants
Patient will receive by mail a kit containing swab for the nares, armpit and groin. In addition the patient will receive decolonization treatment including povidone-iodine soap for presurgical cleansing two days prior to surgery.
Swab and decolonization using povidone-iodine cleansing: Patient in this group will receive improved environmental cleaning and undergo surveillance using swabs and decolonization cleansing.
|
|---|---|---|
|
Quantitate the Reduction of S. Aureus Tranmission
|
1.25 events
Standard Deviation 2.11
|
0.47 events
Standard Deviation 1.13
|
SECONDARY outcome
Timeframe: PreoperativeTo identify the number of patients in the preoperative setting who test positive for S. aureus.
Outcome measures
| Measure |
Standard of Care
n=130 Participants
Patient will receive by mail a kit containing swab for the nares, armpit and groin.
|
Swab Kit Plus Povidone-iodine Soap
n=106 Participants
Patient will receive by mail a kit containing swab for the nares, armpit and groin. In addition the patient will receive decolonization treatment including povidone-iodine soap for presurgical cleansing two days prior to surgery.
Swab and decolonization using povidone-iodine cleansing: Patient in this group will receive improved environmental cleaning and undergo surveillance using swabs and decolonization cleansing.
|
|---|---|---|
|
Identify the Number of Preoperative Patients Positive for S. Aureus Using Collection Kits
|
18 number of participants
|
8 number of participants
|
Adverse Events
Standard of Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Swab Kit Plus Povidone-iodine Soap
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place