Trial Outcomes & Findings for De-Implementation of Unnecessary Surgical Antibiotic Prophylaxis in Children (NCT NCT04366440)
NCT ID: NCT04366440
Last Updated: 2026-07-09
Results Overview
Clean and clean-contaminated surgical cases in children were assessed for whether they received post operative prophylaxis utilizing the Pediatric National Surgical Quality Improvement Project (NSQIP) database. A percentage was determined with the numerator being total number of clean and clean-contaminated cases receiving post operative surgical prophylaxis and the denominator is the total number of clean and clean-contaminated cases. The percentage of cases reflect the percentage of participants who received post operative surgical prophylaxis
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
18267 participants
Primary outcome timeframe
3 years
Results posted on
2026-07-09
Participant Flow
Unit of analysis: Hospital
Participant milestones
| Measure |
Sequence 1: Baseline (6 Months) ASP Facilitation (30 Months)
Baseline: Order set review and modification: The antimicrobial stewardship program worked to eliminate unnecessary post-operative antibiotics by reviewing and changing order sets of clean or clean-contaminated procedures.
ASP facilitation: The antimicrobial stewardship program received facilitation training to aid in reviewing and changing order sets of clean or clean-contaminated procedures to eliminate unnecessary post-operative antibiotics.
|
Sequence 2: Baseline (12 Months) ASP Facilitation (24 Months)
Baseline: Order set review and modification: The antimicrobial stewardship program worked to eliminate unnecessary post-operative antibiotics by reviewing and changing order sets of clean or clean-contaminated procedures.
ASP facilitation: The antimicrobial stewardship program received facilitation training to aid in reviewing and changing order sets of clean or clean-contaminated procedures to eliminate unnecessary post-operative antibiotics.
|
Sequence 3: Baseline (18 Months) ASP Facilitation (18 Months)
Baseline: Order set review and modification: The antimicrobial stewardship program worked to eliminate unnecessary post-operative antibiotics by reviewing and changing order sets of clean or clean-contaminated procedures.
ASP facilitation: The antimicrobial stewardship program received facilitation training to aid in reviewing and changing order sets of clean or clean-contaminated procedures to eliminate unnecessary post-operative antibiotics.
|
|---|---|---|---|
|
Step 3
ASP Facilitation
|
835 3
|
1066 3
|
1068 3
|
|
Step 0
STARTED
|
1157 3
|
831 3
|
1000 3
|
|
Step 0
Baseline
|
1156 3
|
830 3
|
999 3
|
|
Step 0
ASP Facilitation
|
0 0
|
0 0
|
0 0
|
|
Step 0
COMPLETED
|
1157 3
|
831 3
|
1000 3
|
|
Step 0
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
|
Step 1
STARTED
|
1115 3
|
981 3
|
1038 3
|
|
Step 1
Baseline
|
0 0
|
981 3
|
1038 3
|
|
Step 1
ASP Facilitation
|
1115 3
|
0 0
|
0 0
|
|
Step 1
COMPLETED
|
1115 3
|
981 3
|
1038 3
|
|
Step 1
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
|
Step 2
STARTED
|
818 3
|
997 3
|
906 3
|
|
Step 2
Baseline
|
0 0
|
0 0
|
906 3
|
|
Step 2
ASP Facilitation
|
818 3
|
997 3
|
0 0
|
|
Step 2
COMPLETED
|
818 3
|
997 3
|
906 3
|
|
Step 2
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
|
Step 3
STARTED
|
804 3
|
1035 3
|
1036 3
|
|
Step 3
Baseline
|
0 0
|
0 0
|
0 0
|
|
Step 3
COMPLETED
|
804 3
|
1035 3
|
1036 3
|
|
Step 3
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
|
Step 4
STARTED
|
1048 3
|
1033 3
|
1156 3
|
|
Step 4
Baseline
|
0 0
|
0 0
|
0 0
|
|
Step 4
ASP Facilitation
|
1048 3
|
1033 3
|
1056 3
|
|
Step 4
COMPLETED
|
1048 3
|
1033 3
|
1156 3
|
|
Step 4
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
|
Step 5
STARTED
|
1082 3
|
1094 3
|
1145 3
|
|
Step 5
Baseline
|
0 0
|
0 0
|
0 0
|
|
Step 5
ASP Facilitation
|
1082 3
|
1094 3
|
1145 3
|
|
Step 5
COMPLETED
|
1082 3
|
1094 3
|
1145 3
|
|
Step 5
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
De-Implementation of Unnecessary Surgical Antibiotic Prophylaxis in Children
Baseline characteristics by cohort
| Measure |
Order Set Review and Modification
n=5910 Participants
The antimicrobial stewardship program reviewed and changed order sets of clean or clean-contaminated procedures to eliminate unnecessary post-operative antibiotics.
Order set review and modification: The antimicrobial stewardship program worked to eliminate unnecessary post-operative antibiotics by reviewing and changing order sets of clean or clean-contaminated procedures.
|
Order Set Review and Modification Plus Facilitation
n=12357 Participants
The antimicrobial stewardship program received facilitation training to aid in reviewing and changing order sets of clean or clean-contaminated procedures to eliminate unnecessary post-operative antibiotics.
Order set review and modification with facilitation: The antimicrobial stewardship program received facilitation training to aid in reviewing and changing order sets of clean or clean-contaminated procedures to eliminate unnecessary post-operative antibiotics.
|
Total
n=18267 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
8.5 years
n=20 Participants
|
9.4 years
n=20 Participants
|
9.2 years
n=40 Participants
|
|
Sex: Female, Male
Female
|
2977 Participants
n=20 Participants
|
6263 Participants
n=20 Participants
|
9240 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
2933 Participants
n=20 Participants
|
6094 Participants
n=20 Participants
|
9027 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
458 Participants
n=20 Participants
|
1110 Participants
n=20 Participants
|
1568 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Other
|
1176 Participants
n=20 Participants
|
2526 Participants
n=20 Participants
|
3702 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
White
|
4276 Participants
n=20 Participants
|
8721 Participants
n=20 Participants
|
12997 Participants
n=40 Participants
|
|
Region of Enrollment
United States
|
5910 Participants
n=20 Participants
|
12357 Participants
n=20 Participants
|
18267 Participants
n=40 Participants
|
|
American Society of Anesthesiologists (ASA) score
ASA 1-2
|
3575 Participants
n=20 Participants
|
7622 Participants
n=20 Participants
|
11197 Participants
n=40 Participants
|
|
American Society of Anesthesiologists (ASA) score
ASA 3-5
|
2335 Participants
n=20 Participants
|
4735 Participants
n=20 Participants
|
7070 Participants
n=40 Participants
|
|
Insurance Type
Private
|
2441 Participants
n=20 Participants
|
5145 Participants
n=20 Participants
|
7586 Participants
n=40 Participants
|
|
Insurance Type
Public/Self Pay/Unknown
|
3469 Participants
n=20 Participants
|
7212 Participants
n=20 Participants
|
10681 Participants
n=40 Participants
|
|
Surgical Specialty
General Surgery
|
1268 Participants
n=20 Participants
|
2542 Participants
n=20 Participants
|
3810 Participants
n=40 Participants
|
|
Surgical Specialty
Neurosurgery
|
1239 Participants
n=20 Participants
|
2485 Participants
n=20 Participants
|
3724 Participants
n=40 Participants
|
|
Surgical Specialty
Orthopedic Surgery
|
1702 Participants
n=20 Participants
|
3993 Participants
n=20 Participants
|
5695 Participants
n=40 Participants
|
|
Surgical Specialty
Other
|
1701 Participants
n=20 Participants
|
3337 Participants
n=20 Participants
|
5038 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: 3 yearsClean and clean-contaminated surgical cases in children were assessed for whether they received post operative prophylaxis utilizing the Pediatric National Surgical Quality Improvement Project (NSQIP) database. A percentage was determined with the numerator being total number of clean and clean-contaminated cases receiving post operative surgical prophylaxis and the denominator is the total number of clean and clean-contaminated cases. The percentage of cases reflect the percentage of participants who received post operative surgical prophylaxis
Outcome measures
| Measure |
Order Set Review and Modification
n=5910 Cases
The antimicrobial stewardship program reviewed and changed order sets of clean or clean-contaminated procedures to eliminate unnecessary post-operative antibiotics.
Order set review and modification: The antimicrobial stewardship program worked to eliminate unnecessary post-operative antibiotics by reviewing and changing order sets of clean or clean-contaminated procedures.
|
Order Set Review and Modification Plus Facilitation
n=12357 Cases
The antimicrobial stewardship program received facilitation training to aid in reviewing and changing order sets of clean or clean-contaminated procedures to eliminate unnecessary post-operative antibiotics.
Order set review and modification with facilitation: The antimicrobial stewardship program received facilitation training to aid in reviewing and changing order sets of clean or clean-contaminated procedures to eliminate unnecessary post-operative antibiotics.
|
|---|---|---|
|
Percentage of Clean and Clean-contaminated Cases in Children Receiving Post-operative Antibiotic Prophylaxis.
|
9.98 percentage of cases
Interval 8.0 to 13.0
|
10.54 percentage of cases
Interval 9.0 to 13.0
|
SECONDARY outcome
Timeframe: 3 yearsAmong the captured clean and clean-contaminated cases utilized in the primary outcome, the SSI rate per 100 cases was determined in patients both receiving and not receiving post-operative antibiotic prophylaxis.
Outcome measures
| Measure |
Order Set Review and Modification
n=5910 Cases
The antimicrobial stewardship program reviewed and changed order sets of clean or clean-contaminated procedures to eliminate unnecessary post-operative antibiotics.
Order set review and modification: The antimicrobial stewardship program worked to eliminate unnecessary post-operative antibiotics by reviewing and changing order sets of clean or clean-contaminated procedures.
|
Order Set Review and Modification Plus Facilitation
n=12357 Cases
The antimicrobial stewardship program received facilitation training to aid in reviewing and changing order sets of clean or clean-contaminated procedures to eliminate unnecessary post-operative antibiotics.
Order set review and modification with facilitation: The antimicrobial stewardship program received facilitation training to aid in reviewing and changing order sets of clean or clean-contaminated procedures to eliminate unnecessary post-operative antibiotics.
|
|---|---|---|
|
Rate of Surgical Site Infections (SSI) in Clean and Clean-contaminated Cases
|
1.96 number of infections per 100 cases
Interval 1.62 to 2.35
|
2.03 number of infections per 100 cases
Interval 1.79 to 2.3
|
SECONDARY outcome
Timeframe: 3 yearsAmong the captured clean and clean-contaminated cases utilized in the primary outcome, the CDI rate per 100 cases was determined in patients both receiving and not receiving post-operative antibiotic prophylaxis
Outcome measures
| Measure |
Order Set Review and Modification
n=5910 Cases
The antimicrobial stewardship program reviewed and changed order sets of clean or clean-contaminated procedures to eliminate unnecessary post-operative antibiotics.
Order set review and modification: The antimicrobial stewardship program worked to eliminate unnecessary post-operative antibiotics by reviewing and changing order sets of clean or clean-contaminated procedures.
|
Order Set Review and Modification Plus Facilitation
n=12357 Cases
The antimicrobial stewardship program received facilitation training to aid in reviewing and changing order sets of clean or clean-contaminated procedures to eliminate unnecessary post-operative antibiotics.
Order set review and modification with facilitation: The antimicrobial stewardship program received facilitation training to aid in reviewing and changing order sets of clean or clean-contaminated procedures to eliminate unnecessary post-operative antibiotics.
|
|---|---|---|
|
Rate of Clostridioides Difficile Infections (CDI) in Clean and Clean-contaminated Cases
|
0.15 number of infections per 100 cases
Interval 0.07 to 0.29
|
0.06 number of infections per 100 cases
Interval 0.03 to 0.13
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 yearsA validated 4 question survey will be used to assess the acceptability of each intervention.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 yearsA validated 4 question survey will be used to assess the feasibility of each intervention.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 yearsA validated 4 question survey will be used to assess the appropriateness of each intervention.
Outcome measures
Outcome data not reported
Adverse Events
Order Set Review and Modification
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Order Set Review and Modification Plus Facilitation
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