Trial Outcomes & Findings for The Skin Prep Study (NCT NCT01472549)
NCT ID: NCT01472549
Last Updated: 2018-08-08
Results Overview
Superficial or deep surgical-site infection within 30 days after cesarean delivery, on the basis of the National Healthcare Safety Network definitions of the Centers for Disease Control and Prevention.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1147 participants
Primary outcome timeframe
30 days
Results posted on
2018-08-08
Participant Flow
In this single-center, randomized, controlled trial, a total of 1147 patients were enrolled from September 2011 through June 2015.
Participant milestones
| Measure |
Chlorhexidine-alcohol
2% chlorhexidine gluconate with 70% alcohol (ChloraPrep, Cardinal Health)
Chlorhexidine-alcohol: Skin preparation with 2% chlorhexidine gluconate with 70% alcohol (ChloraPrep, Cardinal Health) preoperative skin preparation
|
Iodine-alcohol
8.3% povidone-iodine with 72.5% alcohol (Prevail-FX, Cardinal Health)
Iodine-alcohol: Skin preparation with 8.3% povidone-iodine with 72.5% alcohol (Prevail-FX, Cardinal Health) preoperative skin preparation.
|
|---|---|---|
|
Overall Study
STARTED
|
572
|
575
|
|
Overall Study
COMPLETED
|
572
|
575
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Skin Prep Study
Baseline characteristics by cohort
| Measure |
Chlorhexidine-alcohol
n=572 Participants
2% chlorhexidine gluconate with 70% alcohol (ChloraPrep, Cardinal Health)
Chlorhexidine-alcohol: Skin preparation with 2% chlorhexidine gluconate with 70% alcohol (ChloraPrep, Cardinal Health) preoperative skin preparation
|
Iodine-alcohol
n=575 Participants
8.3% povidone-iodine with 72.5% alcohol (Prevail-FX, Cardinal Health)
Iodine-alcohol: Skin preparation with 8.3% povidone-iodine with 72.5% alcohol (Prevail-FX, Cardinal Health) preoperative skin preparation.
|
Total
n=1147 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
28.3 years
STANDARD_DEVIATION 5.8 • n=99 Participants
|
28.4 years
STANDARD_DEVIATION 5.8 • n=107 Participants
|
28.4 years
STANDARD_DEVIATION 5.8 • n=206 Participants
|
|
Sex: Female, Male
Female
|
572 Participants
n=99 Participants
|
575 Participants
n=107 Participants
|
1147 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
572 participants
n=99 Participants
|
575 participants
n=107 Participants
|
1147 participants
n=206 Participants
|
|
Body mass index
|
35.1 kg/m2
STANDARD_DEVIATION 8.9 • n=99 Participants
|
34.1 kg/m2
STANDARD_DEVIATION 8.1 • n=107 Participants
|
34.6 kg/m2
STANDARD_DEVIATION 8.5 • n=206 Participants
|
|
Scheduled cesarean
|
334 Participants
n=99 Participants
|
335 Participants
n=107 Participants
|
669 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 30 daysSuperficial or deep surgical-site infection within 30 days after cesarean delivery, on the basis of the National Healthcare Safety Network definitions of the Centers for Disease Control and Prevention.
Outcome measures
| Measure |
Iodine-alcohol
n=575 Participants
8.3% povidone-iodine with 72.5% alcohol (Prevail-FX, Cardinal Health)
Iodine-alcohol: Skin preparation with 8.3% povidone-iodine with 72.5% alcohol (Prevail-FX, Cardinal Health) preoperative skin preparation.
|
Chlorhexidine-alcohol
n=572 Participants
2% chlorhexidine gluconate with 70% alcohol (ChloraPrep, Cardinal Health)
Chlorhexidine-alcohol: Skin preparation with 2% chlorhexidine gluconate with 70% alcohol (ChloraPrep, Cardinal Health) preoperative skin preparation
|
|---|---|---|
|
Number of Participants With Surgical Site Infection
|
42 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: 30 daysOutcome measures
| Measure |
Iodine-alcohol
n=575 Participants
8.3% povidone-iodine with 72.5% alcohol (Prevail-FX, Cardinal Health)
Iodine-alcohol: Skin preparation with 8.3% povidone-iodine with 72.5% alcohol (Prevail-FX, Cardinal Health) preoperative skin preparation.
|
Chlorhexidine-alcohol
n=572 Participants
2% chlorhexidine gluconate with 70% alcohol (ChloraPrep, Cardinal Health)
Chlorhexidine-alcohol: Skin preparation with 2% chlorhexidine gluconate with 70% alcohol (ChloraPrep, Cardinal Health) preoperative skin preparation
|
|---|---|---|
|
Length of Hospital Stay
|
4 days
Interval 3.0 to 4.0
|
4 days
Interval 3.0 to 4.0
|
SECONDARY outcome
Timeframe: 30 daysOutcome measures
| Measure |
Iodine-alcohol
n=575 Participants
8.3% povidone-iodine with 72.5% alcohol (Prevail-FX, Cardinal Health)
Iodine-alcohol: Skin preparation with 8.3% povidone-iodine with 72.5% alcohol (Prevail-FX, Cardinal Health) preoperative skin preparation.
|
Chlorhexidine-alcohol
n=572 Participants
2% chlorhexidine gluconate with 70% alcohol (ChloraPrep, Cardinal Health)
Chlorhexidine-alcohol: Skin preparation with 2% chlorhexidine gluconate with 70% alcohol (ChloraPrep, Cardinal Health) preoperative skin preparation
|
|---|---|---|
|
Number of Participants With Re-admissions or Office Visits for Wound-related Problems
|
25 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: 30 daysOutcome measures
| Measure |
Iodine-alcohol
n=575 Participants
8.3% povidone-iodine with 72.5% alcohol (Prevail-FX, Cardinal Health)
Iodine-alcohol: Skin preparation with 8.3% povidone-iodine with 72.5% alcohol (Prevail-FX, Cardinal Health) preoperative skin preparation.
|
Chlorhexidine-alcohol
n=572 Participants
2% chlorhexidine gluconate with 70% alcohol (ChloraPrep, Cardinal Health)
Chlorhexidine-alcohol: Skin preparation with 2% chlorhexidine gluconate with 70% alcohol (ChloraPrep, Cardinal Health) preoperative skin preparation
|
|---|---|---|
|
Number of Participants With Endometritis
|
11 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 30 daysOutcome measures
| Measure |
Iodine-alcohol
n=575 Participants
8.3% povidone-iodine with 72.5% alcohol (Prevail-FX, Cardinal Health)
Iodine-alcohol: Skin preparation with 8.3% povidone-iodine with 72.5% alcohol (Prevail-FX, Cardinal Health) preoperative skin preparation.
|
Chlorhexidine-alcohol
n=572 Participants
2% chlorhexidine gluconate with 70% alcohol (ChloraPrep, Cardinal Health)
Chlorhexidine-alcohol: Skin preparation with 2% chlorhexidine gluconate with 70% alcohol (ChloraPrep, Cardinal Health) preoperative skin preparation
|
|---|---|---|
|
Number of Participants With Skin Irritation
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 30 daysOutcome measures
| Measure |
Iodine-alcohol
n=575 Participants
8.3% povidone-iodine with 72.5% alcohol (Prevail-FX, Cardinal Health)
Iodine-alcohol: Skin preparation with 8.3% povidone-iodine with 72.5% alcohol (Prevail-FX, Cardinal Health) preoperative skin preparation.
|
Chlorhexidine-alcohol
n=572 Participants
2% chlorhexidine gluconate with 70% alcohol (ChloraPrep, Cardinal Health)
Chlorhexidine-alcohol: Skin preparation with 2% chlorhexidine gluconate with 70% alcohol (ChloraPrep, Cardinal Health) preoperative skin preparation
|
|---|---|---|
|
Number of Participants With Allergic Reaction
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 1 dayPopulation: The skin samples collected could not be processed for financial reasons.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 daysPopulation: Cost data was not collected because it as not logistically feasible.
Outcome measures
Outcome data not reported
Adverse Events
Chlorhexidine-alcohol
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Iodine-alcohol
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 |
Chlorhexidine-alcohol
n=572 participants at risk
2% chlorhexidine gluconate with 70% alcohol (ChloraPrep, Cardinal Health)
Chlorhexidine-alcohol: Skin preparation with 2% chlorhexidine gluconate with 70% alcohol (ChloraPrep, Cardinal Health) preoperative skin preparation
|
Iodine-alcohol
n=575 participants at risk
8.3% povidone-iodine with 72.5% alcohol (Prevail-FX, Cardinal Health)
Iodine-alcohol: Skin preparation with 8.3% povidone-iodine with 72.5% alcohol (Prevail-FX, Cardinal Health) preoperative skin preparation.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Adverse skin reactions
|
2.6%
15/572 • Number of events 15 • 30 days
|
2.6%
15/575 • Number of events 15 • 30 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place