Trial Outcomes & Findings for STRIPES Study: Study To Reduce Infection Post cEsarean Section (NCT NCT02402907)
NCT ID: NCT02402907
Last Updated: 2020-11-09
Results Overview
Number of participants with Incisional Surgical Site Infection (SSI)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1356 participants
Primary outcome timeframe
at 6 weeks
Results posted on
2020-11-09
Participant Flow
1356 were enrolled, 14 did not undergo procedure at Sinai, leaving 1342 participants (672 in experimental group and 670 in placebo group) that continued on the study.
Participant milestones
| Measure |
CHG Cloth
2% chlorhexidine gluconate (CHG) cloth: administration of a 2% CHG cloth at home on the night before and approximately 3 hours prior to cesarean delivery on the morning of the surgery.
|
Placebo Cloth
Placebo cloth: administration of a fragrance free cleansing cloth with the placebo (commercial cleansing cloth) at home on the night before and approximately 3 hours prior to cesarean delivery on the morning of the surgery.
|
|---|---|---|
|
Overall Study
STARTED
|
682
|
674
|
|
Overall Study
COMPLETED
|
662
|
647
|
|
Overall Study
NOT COMPLETED
|
20
|
27
|
Reasons for withdrawal
| Measure |
CHG Cloth
2% chlorhexidine gluconate (CHG) cloth: administration of a 2% CHG cloth at home on the night before and approximately 3 hours prior to cesarean delivery on the morning of the surgery.
|
Placebo Cloth
Placebo cloth: administration of a fragrance free cleansing cloth with the placebo (commercial cleansing cloth) at home on the night before and approximately 3 hours prior to cesarean delivery on the morning of the surgery.
|
|---|---|---|
|
Overall Study
Delivered vaginally
|
9
|
3
|
|
Overall Study
Delivered outside of Sinai
|
1
|
1
|
|
Overall Study
Lost to follow up after C-Section
|
10
|
23
|
Baseline Characteristics
Data results only for those participants who underwent C-Section at Sinai
Baseline characteristics by cohort
| Measure |
CHG Cloth
n=682 Participants
2% chlorhexidine gluconate (CHG) cloth: administration of a 2% CHG cloth at home on the night before and approximately 3 hours prior to cesarean delivery on the morning of the surgery.
|
Placebo Cloth
n=674 Participants
Placebo cloth: administration of a fragrance free cleansing cloth with the placebo (commercial cleansing cloth) at home on the night before and approximately 3 hours prior to cesarean delivery on the morning of the surgery.
|
Total
n=1356 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35.1 years
STANDARD_DEVIATION 5.0 • n=682 Participants
|
35.1 years
STANDARD_DEVIATION 5.0 • n=674 Participants
|
35.1 years
STANDARD_DEVIATION 5.0 • n=1356 Participants
|
|
Sex: Female, Male
Female
|
682 Participants
n=682 Participants
|
674 Participants
n=674 Participants
|
1356 Participants
n=1356 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=682 Participants
|
0 Participants
n=674 Participants
|
0 Participants
n=1356 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
66 Participants
n=682 Participants
|
60 Participants
n=674 Participants
|
126 Participants
n=1356 Participants
|
|
Race/Ethnicity, Customized
White
|
436 Participants
n=682 Participants
|
416 Participants
n=674 Participants
|
852 Participants
n=1356 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
113 Participants
n=682 Participants
|
121 Participants
n=674 Participants
|
234 Participants
n=1356 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
67 Participants
n=682 Participants
|
77 Participants
n=674 Participants
|
144 Participants
n=1356 Participants
|
|
Private Insurance
|
604 Participants
n=682 Participants
|
577 Participants
n=674 Participants
|
1181 Participants
n=1356 Participants
|
|
Chronic Hypertension
|
23 Participants
n=682 Participants
|
26 Participants
n=674 Participants
|
49 Participants
n=1356 Participants
|
|
Pregestational Diabetes
|
9 Participants
n=682 Participants
|
13 Participants
n=674 Participants
|
22 Participants
n=1356 Participants
|
|
Asthma
|
47 Participants
n=682 Participants
|
28 Participants
n=674 Participants
|
75 Participants
n=1356 Participants
|
|
Primiparous
|
248 Participants
n=682 Participants
|
236 Participants
n=674 Participants
|
484 Participants
n=1356 Participants
|
|
Repeat Cesarean Delivery
|
387 Participants
n=682 Participants
|
394 Participants
n=674 Participants
|
781 Participants
n=1356 Participants
|
|
Gestational Hypertension
|
17 Participants
n=682 Participants
|
18 Participants
n=674 Participants
|
35 Participants
n=1356 Participants
|
|
Gestational Diabetes
|
69 Participants
n=682 Participants
|
57 Participants
n=674 Participants
|
126 Participants
n=1356 Participants
|
|
Preeclampsia
|
8 Participants
n=682 Participants
|
13 Participants
n=674 Participants
|
21 Participants
n=1356 Participants
|
|
Cholestasis
|
8 Participants
n=682 Participants
|
7 Participants
n=674 Participants
|
15 Participants
n=1356 Participants
|
|
Estimated Blood loss
|
719.5 mL
n=672 Participants • Data results only for those participants who underwent C-Section at Sinai
|
717.5 mL
n=670 Participants • Data results only for those participants who underwent C-Section at Sinai
|
718.5 mL
n=1342 Participants • Data results only for those participants who underwent C-Section at Sinai
|
|
Length of procedure
|
62.0 min
n=672 Participants • Data results only for those participants who underwent C-Section at Sinai
|
62.0 min
n=670 Participants • Data results only for those participants who underwent C-Section at Sinai
|
62.0 min
n=1342 Participants • Data results only for those participants who underwent C-Section at Sinai
|
|
Preincision Prophylactic Antibiotics
Clindamycin/gentamicin
|
14 Participants
n=672 Participants • Data results only for those participants who underwent C-Section at Sinai
|
12 Participants
n=670 Participants • Data results only for those participants who underwent C-Section at Sinai
|
26 Participants
n=1342 Participants • Data results only for those participants who underwent C-Section at Sinai
|
|
Preincision Prophylactic Antibiotics
Cefazolin
|
645 Participants
n=682 Participants • Data results only for those participants who underwent C-Section at Sinai
|
648 Participants
n=674 Participants • Data results only for those participants who underwent C-Section at Sinai
|
1293 Participants
n=1356 Participants • Data results only for those participants who underwent C-Section at Sinai
|
|
Skin Closure Type
Staples
|
56 Participants
n=672 Participants • Data results only for those participants who underwent C-Section at Sinai
|
58 Participants
n=670 Participants • Data results only for those participants who underwent C-Section at Sinai
|
114 Participants
n=1342 Participants • Data results only for those participants who underwent C-Section at Sinai
|
|
Skin Closure Type
Subcuticular suture
|
616 Participants
n=682 Participants • Data results only for those participants who underwent C-Section at Sinai
|
612 Participants
n=674 Participants • Data results only for those participants who underwent C-Section at Sinai
|
1228 Participants
n=1356 Participants • Data results only for those participants who underwent C-Section at Sinai
|
PRIMARY outcome
Timeframe: at 6 weeksNumber of participants with Incisional Surgical Site Infection (SSI)
Outcome measures
| Measure |
CHG Cloth
n=662 Participants
2% chlorhexidine gluconate (CHG) cloth: administration of a 2% CHG cloth at home on the night before and approximately 3 hours prior to cesarean delivery on the morning of the surgery.
|
Placebo Cloth
n=647 Participants
Placebo cloth: administration of a fragrance free cleansing cloth with the placebo (commercial cleansing cloth) at home on the night before and approximately 3 hours prior to cesarean delivery on the morning of the surgery.
|
|---|---|---|
|
Number of Participants With Incisional SSI
|
17 Participants
|
24 Participants
|
PRIMARY outcome
Timeframe: at 6 weeksPopulation: participants with full adherence to protocol and available for assessment at 6 weeks
Among those with full adherence to the protocol and who were available for assessment at 6 weeks. Adherence to the protocol was assessed in the following 2 ways: evaluation of returned packages on the day of surgery and report ascertained by phone interview at 2 weeks.
Outcome measures
| Measure |
CHG Cloth
n=524 Participants
2% chlorhexidine gluconate (CHG) cloth: administration of a 2% CHG cloth at home on the night before and approximately 3 hours prior to cesarean delivery on the morning of the surgery.
|
Placebo Cloth
n=515 Participants
Placebo cloth: administration of a fragrance free cleansing cloth with the placebo (commercial cleansing cloth) at home on the night before and approximately 3 hours prior to cesarean delivery on the morning of the surgery.
|
|---|---|---|
|
Number of Adherent Participants With Incisional SSI
|
10 Participants
|
17 Participants
|
PRIMARY outcome
Timeframe: at 6 weeksNumber of participants with endometritis
Outcome measures
| Measure |
CHG Cloth
n=662 Participants
2% chlorhexidine gluconate (CHG) cloth: administration of a 2% CHG cloth at home on the night before and approximately 3 hours prior to cesarean delivery on the morning of the surgery.
|
Placebo Cloth
n=647 Participants
Placebo cloth: administration of a fragrance free cleansing cloth with the placebo (commercial cleansing cloth) at home on the night before and approximately 3 hours prior to cesarean delivery on the morning of the surgery.
|
|---|---|---|
|
Number of Participants With Endometritis
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: up to 6 weeksPopulation: Data results only for those participants who underwent C-Section at Sinai
Number of participants with maternal complications
Outcome measures
| Measure |
CHG Cloth
n=672 Participants
2% chlorhexidine gluconate (CHG) cloth: administration of a 2% CHG cloth at home on the night before and approximately 3 hours prior to cesarean delivery on the morning of the surgery.
|
Placebo Cloth
n=670 Participants
Placebo cloth: administration of a fragrance free cleansing cloth with the placebo (commercial cleansing cloth) at home on the night before and approximately 3 hours prior to cesarean delivery on the morning of the surgery.
|
|---|---|---|
|
Number of Participants With Maternal Complications
Erythema at operative site
|
16 Participants
|
16 Participants
|
|
Number of Participants With Maternal Complications
Skin Separation
|
19 Participants
|
23 Participants
|
|
Number of Participants With Maternal Complications
Drainage
|
21 Participants
|
16 Participants
|
|
Number of Participants With Maternal Complications
Fever
|
4 Participants
|
2 Participants
|
|
Number of Participants With Maternal Complications
Hematoma
|
1 Participants
|
5 Participants
|
|
Number of Participants With Maternal Complications
Seroma
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: up to 6 weeksPopulation: Data not collected
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: at 6 weeksPopulation: data for participants who were hospitalized
Length of stay (index hospitalization)
Outcome measures
| Measure |
CHG Cloth
n=652 Participants
2% chlorhexidine gluconate (CHG) cloth: administration of a 2% CHG cloth at home on the night before and approximately 3 hours prior to cesarean delivery on the morning of the surgery.
|
Placebo Cloth
n=651 Participants
Placebo cloth: administration of a fragrance free cleansing cloth with the placebo (commercial cleansing cloth) at home on the night before and approximately 3 hours prior to cesarean delivery on the morning of the surgery.
|
|---|---|---|
|
Maternal Length of Stay
|
3.0 days
Interval 3.0 to 3.0
|
3.0 days
Interval 3.0 to 3.0
|
SECONDARY outcome
Timeframe: up to 6 weeksPopulation: Data results only for those participants who underwent C-Section at Sinai. unable to obtain data for 2 participants in placebo cloth arm
Number of participants with hospital readmission for wound complication
Outcome measures
| Measure |
CHG Cloth
n=672 Participants
2% chlorhexidine gluconate (CHG) cloth: administration of a 2% CHG cloth at home on the night before and approximately 3 hours prior to cesarean delivery on the morning of the surgery.
|
Placebo Cloth
n=668 Participants
Placebo cloth: administration of a fragrance free cleansing cloth with the placebo (commercial cleansing cloth) at home on the night before and approximately 3 hours prior to cesarean delivery on the morning of the surgery.
|
|---|---|---|
|
Number of Participants With Maternal Readmissions
|
5 Participants
|
3 Participants
|
Adverse Events
CHG Cloth
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Cloth
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
Dr. Joanne Stone
Icahn School of Medicine at Mount Sinai
Phone: 212-241-5681
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place