Trial Outcomes & Findings for Antibacterial-coated Sutures at Time of Cesarean (NCT NCT03386240)
NCT ID: NCT03386240
Last Updated: 2026-06-22
Results Overview
Number of Participants With Endometritis, Wound Infection, or Other Post-Cesarean Infections post-cesarean infections occurring within 30 days of delivery, including endometritis, wound infection, or other infections. Endometritis: Presence of two or more of the following signs with no other identified etiology: fever (\>38°C or \>100.4°F), abdominal pain, fundal tenderness, or cervical/vaginal purulent discharge. Wound Infection: Presence of superficial or deep incisional surgical site infection (SSI), including cellulitis/erythema, induration around the incision, or purulent discharge from the incision site with or without fever, including necrotizing fasciitis. Wound hematoma, seroma, or wound breakdown alone without signs of infection was not considered infection. Other Infections: Pelvic septic thrombosis diagnosed based on persistent signs of endometritis with or without radiologic confirmation, or abdominal/pelvic abscess confirmed radiologically.
TERMINATED
PHASE4
1169 participants
Within 30 days following delivery
2026-06-22
Participant Flow
Participant milestones
| Measure |
Vicryl-plus, Monocryl-plus, PDS-plus (Triclosan-coated Sutures
Use of Monocryl Plus, Vicryl Plus and PDS Plus Suture (Triclosan-coated sutures) will be used exclusively throughout the entire procedure.
Vicryl-plus, monocryl-plus, PDS-plus (Triclosan-coated Sutures): The intervention consists of using Plus group (Triclosan-coated Sutures)
|
Vicryl, Monocryl, PDS (Not Coated With Triclosan)
Use of Monocryl, Vicryl and PDS Suture (equivalent uncoated sutures) will be used exclusively throughout the whole procedure.
Vicryl, monocryl, PDS (not coated with triclosan): Consists of equivalent sutures (not coated with triclosan) during cesarean delivery.
|
|---|---|---|
|
Overall Study
STARTED
|
585
|
584
|
|
Overall Study
COMPLETED
|
585
|
584
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Antibacterial-coated Sutures at Time of Cesarean
Baseline characteristics by cohort
| Measure |
Vicryl-plus, Monocryl-plus, PDS-plus (Triclosan-coated Sutures
n=585 Participants
Use of Monocryl Plus, Vicryl Plus and PDS Plus Suture (Triclosan-coated sutures) will be used exclusively throughout the entire procedure.
Vicryl-plus, monocryl-plus, PDS-plus (Triclosan-coated Sutures): The intervention consists of using Plus group (Triclosan-coated Sutures)
|
Vicryl, Monocryl, PDS (Not Coated With Triclosan)
n=584 Participants
Use of Monocryl, Vicryl and PDS Suture (equivalent uncoated sutures) will be used exclusively throughout the whole procedure.
Vicryl, monocryl, PDS (not coated with triclosan): Consists of equivalent sutures (not coated with triclosan) during cesarean delivery.
|
Total
n=1169 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
585 Participants
n=20 Participants
|
584 Participants
n=20 Participants
|
1169 Participants
n=40 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Sex: Female, Male
Female
|
585 Participants
n=20 Participants
|
584 Participants
n=20 Participants
|
1169 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
413 Participants
n=20 Participants
|
433 Participants
n=20 Participants
|
846 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
172 Participants
n=20 Participants
|
151 Participants
n=20 Participants
|
323 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Region of Enrollment
United States
|
585 participants
n=20 Participants
|
584 participants
n=20 Participants
|
1169 participants
n=40 Participants
|
PRIMARY outcome
Timeframe: Within 30 days following deliveryNumber of Participants With Endometritis, Wound Infection, or Other Post-Cesarean Infections post-cesarean infections occurring within 30 days of delivery, including endometritis, wound infection, or other infections. Endometritis: Presence of two or more of the following signs with no other identified etiology: fever (\>38°C or \>100.4°F), abdominal pain, fundal tenderness, or cervical/vaginal purulent discharge. Wound Infection: Presence of superficial or deep incisional surgical site infection (SSI), including cellulitis/erythema, induration around the incision, or purulent discharge from the incision site with or without fever, including necrotizing fasciitis. Wound hematoma, seroma, or wound breakdown alone without signs of infection was not considered infection. Other Infections: Pelvic septic thrombosis diagnosed based on persistent signs of endometritis with or without radiologic confirmation, or abdominal/pelvic abscess confirmed radiologically.
Outcome measures
| Measure |
Vicryl-plus, Monocryl-plus, PDS-plus (Triclosan-coated Sutures
n=585 Participants
Use of Monocryl Plus, Vicryl Plus and PDS Plus Suture (Triclosan-coated sutures) will be used exclusively throughout the entire procedure.
Vicryl-plus, monocryl-plus, PDS-plus (Triclosan-coated Sutures): The intervention consists of using Plus group (Triclosan-coated Sutures)
|
Vicryl, Monocryl, PDS (Not Coated With Triclosan)
n=584 Participants
Use of Monocryl, Vicryl and PDS Suture (equivalent uncoated sutures) will be used exclusively throughout the whole procedure.
Vicryl, monocryl, PDS (not coated with triclosan): Consists of equivalent sutures (not coated with triclosan) during cesarean delivery.
|
|---|---|---|
|
Participants With Endometritis, Wound Infection, or Other Post-Cesarean Infections
Endometritis
|
2 Participants
|
1 Participants
|
|
Participants With Endometritis, Wound Infection, or Other Post-Cesarean Infections
Wound Infection
|
20 Participants
|
21 Participants
|
|
Participants With Endometritis, Wound Infection, or Other Post-Cesarean Infections
Other Post-Cesarean Infections
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Within 30 days following deliveryNumber of participants who developed a surgical site infection (SSI) following cesarean delivery.
Outcome measures
| Measure |
Vicryl-plus, Monocryl-plus, PDS-plus (Triclosan-coated Sutures
n=585 Participants
Use of Monocryl Plus, Vicryl Plus and PDS Plus Suture (Triclosan-coated sutures) will be used exclusively throughout the entire procedure.
Vicryl-plus, monocryl-plus, PDS-plus (Triclosan-coated Sutures): The intervention consists of using Plus group (Triclosan-coated Sutures)
|
Vicryl, Monocryl, PDS (Not Coated With Triclosan)
n=584 Participants
Use of Monocryl, Vicryl and PDS Suture (equivalent uncoated sutures) will be used exclusively throughout the whole procedure.
Vicryl, monocryl, PDS (not coated with triclosan): Consists of equivalent sutures (not coated with triclosan) during cesarean delivery.
|
|---|---|---|
|
Participants With Surgical Site Infection
|
17 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: Within 30 days following deliveryNumber of Maternal Deaths.
Outcome measures
| Measure |
Vicryl-plus, Monocryl-plus, PDS-plus (Triclosan-coated Sutures
n=585 Participants
Use of Monocryl Plus, Vicryl Plus and PDS Plus Suture (Triclosan-coated sutures) will be used exclusively throughout the entire procedure.
Vicryl-plus, monocryl-plus, PDS-plus (Triclosan-coated Sutures): The intervention consists of using Plus group (Triclosan-coated Sutures)
|
Vicryl, Monocryl, PDS (Not Coated With Triclosan)
n=584 Participants
Use of Monocryl, Vicryl and PDS Suture (equivalent uncoated sutures) will be used exclusively throughout the whole procedure.
Vicryl, monocryl, PDS (not coated with triclosan): Consists of equivalent sutures (not coated with triclosan) during cesarean delivery.
|
|---|---|---|
|
Maternal Deaths
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Within 30 days following deliveryNumber of participants who developed wound hematoma or seroma following cesarean delivery. Wound hematoma was defined as a localized collection of blood at the incision site, and seroma was defined as a localized accumulation of serous fluid at the incision site identified during the postoperative follow-up period.
Outcome measures
| Measure |
Vicryl-plus, Monocryl-plus, PDS-plus (Triclosan-coated Sutures
n=585 Participants
Use of Monocryl Plus, Vicryl Plus and PDS Plus Suture (Triclosan-coated sutures) will be used exclusively throughout the entire procedure.
Vicryl-plus, monocryl-plus, PDS-plus (Triclosan-coated Sutures): The intervention consists of using Plus group (Triclosan-coated Sutures)
|
Vicryl, Monocryl, PDS (Not Coated With Triclosan)
n=584 Participants
Use of Monocryl, Vicryl and PDS Suture (equivalent uncoated sutures) will be used exclusively throughout the whole procedure.
Vicryl, monocryl, PDS (not coated with triclosan): Consists of equivalent sutures (not coated with triclosan) during cesarean delivery.
|
|---|---|---|
|
Participants With Wound Hematoma or Seroma
Wound with Hematoma
|
0 Participants
|
1 Participants
|
|
Participants With Wound Hematoma or Seroma
Wound with Seroma
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Within 30 days following deliveryNumber of participants who developed puerperal fever following cesarean delivery. Puerperal fever was defined as a temperature \>100.4°F occurring after the first 24 hours postpartum or a temperature ≥101°F occurring at any time during the postpartum period.
Outcome measures
| Measure |
Vicryl-plus, Monocryl-plus, PDS-plus (Triclosan-coated Sutures
n=585 Participants
Use of Monocryl Plus, Vicryl Plus and PDS Plus Suture (Triclosan-coated sutures) will be used exclusively throughout the entire procedure.
Vicryl-plus, monocryl-plus, PDS-plus (Triclosan-coated Sutures): The intervention consists of using Plus group (Triclosan-coated Sutures)
|
Vicryl, Monocryl, PDS (Not Coated With Triclosan)
n=584 Participants
Use of Monocryl, Vicryl and PDS Suture (equivalent uncoated sutures) will be used exclusively throughout the whole procedure.
Vicryl, monocryl, PDS (not coated with triclosan): Consists of equivalent sutures (not coated with triclosan) during cesarean delivery.
|
|---|---|---|
|
Participants With Puerperal Fever
|
4 Participants
|
3 Participants
|
Adverse Events
Vicryl-plus, Monocryl-plus, PDS-plus (Triclosan-coated Sutures
Vicryl, Monocryl, PDS (Not Coated With Triclosan)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Vicryl-plus, Monocryl-plus, PDS-plus (Triclosan-coated Sutures
n=585 participants at risk
Use of Monocryl Plus, Vicryl Plus and PDS Plus Suture (Triclosan-coated sutures) will be used exclusively throughout the entire procedure.
Vicryl-plus, monocryl-plus, PDS-plus (Triclosan-coated Sutures): The intervention consists of using Plus group (Triclosan-coated Sutures)
|
Vicryl, Monocryl, PDS (Not Coated With Triclosan)
n=584 participants at risk
Use of Monocryl, Vicryl and PDS Suture (equivalent uncoated sutures) will be used exclusively throughout the whole procedure.
Vicryl, monocryl, PDS (not coated with triclosan): Consists of equivalent sutures (not coated with triclosan) during cesarean delivery.
|
|---|---|---|
|
Renal and urinary disorders
Unanticipated Problem
|
0.17%
1/585 • Number of events 1 • 30 days following delivery
1 AE during the study period was reported. We are unaware of any other adverse events during the study period.
|
0.00%
0/584 • 30 days following delivery
1 AE during the study period was reported. We are unaware of any other adverse events during the study period.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place