Trial Outcomes & Findings for Barbed Suture for Hysterotomy Closure During Cesarean Section (NCT NCT04622267)

NCT ID: NCT04622267

Last Updated: 2024-11-05

Results Overview

Quantification of blood loss (QBL)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 226 participants
• Primary outcome timeframe: Day 1, At delivery
• Results posted on: 2024-11-05

Participant Flow

recruitment and enrollment conducted from 21 July 2021 through 27 November 2023, and was conducted solely at the Icahn School of Medicine at Mount Sinai Hospital Labor & Delivery Unit at 1176 Fifth Avenue, New York, NY 10029.

Participant milestones

Measure	Standard Suture Standard antimicrobial suture (vicryl) to close a C-section incision - control arm	Barbed Suture Barbed suture type is STRATAFIX Symmetric PDS Plus Knotless Tissue to close a C-section incision
Overall Study STARTED	113	113
Overall Study COMPLETED	113	113
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Barbed Suture for Hysterotomy Closure During Cesarean Section

Baseline characteristics by cohort

Measure	Standard Suture n=113 Participants Standard antimicrobial suture (vicryl) to close a C-section incision - control arm	Barbed Suture n=113 Participants Barbed suture type is STRATAFIX Symmetric PDS Plus Knotless Tissue to close a C-section incision	Total n=226 Participants Total of all reporting groups
Age, Continuous	34.7 years STANDARD_DEVIATION 5.0 • n=5 Participants	35.9 years STANDARD_DEVIATION 6.1 • n=7 Participants	35.3 years STANDARD_DEVIATION 5.6 • n=5 Participants
Sex: Female, Male Female	113 Participants n=5 Participants	113 Participants n=7 Participants	226 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	21 Participants n=5 Participants	26 Participants n=7 Participants	47 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	88 Participants n=5 Participants	81 Participants n=7 Participants	169 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	14 Participants n=5 Participants	15 Participants n=7 Participants	29 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Race (NIH/OMB) White	57 Participants n=5 Participants	48 Participants n=7 Participants	105 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	27 Participants n=5 Participants	35 Participants n=7 Participants	62 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1, At delivery

Quantification of blood loss (QBL)

Outcome measures

Measure	Standard Suture n=113 Participants Standard antimicrobial suture (vicryl) to close a C-section incision - control arm	Barbed Suture n=113 Participants Barbed suture type is STRATAFIX Symmetric PDS Plus Knotless Tissue to close a C-section incision
Quantitative Blood Loss	641.8 mL Standard Deviation 300.2	596.5 mL Standard Deviation 283.2

SECONDARY outcome

Timeframe: Day 1, At delivery

Time for hysterotomy closure

Outcome measures

Measure	Standard Suture n=113 Participants Standard antimicrobial suture (vicryl) to close a C-section incision - control arm	Barbed Suture n=113 Participants Barbed suture type is STRATAFIX Symmetric PDS Plus Knotless Tissue to close a C-section incision
Time for Hysterotomy Closure	326.3 seconds Standard Deviation 122.1	277.9 seconds Standard Deviation 97.3

SECONDARY outcome

Timeframe: Day 1, At delivery

Outcome measures

Measure	Standard Suture n=113 Participants Standard antimicrobial suture (vicryl) to close a C-section incision - control arm	Barbed Suture n=113 Participants Barbed suture type is STRATAFIX Symmetric PDS Plus Knotless Tissue to close a C-section incision
Number of Participants Who Need Additional Hemostatic Sutures	50 Participants	67 Participants

SECONDARY outcome

Timeframe: Day 1, At delivery

Number of hemostatic sutures needed during procedure

Outcome measures

Measure	Standard Suture n=113 Participants Standard antimicrobial suture (vicryl) to close a C-section incision - control arm	Barbed Suture n=113 Participants Barbed suture type is STRATAFIX Symmetric PDS Plus Knotless Tissue to close a C-section incision
Number of Hemostatic Sutures	1.1 sutures Standard Deviation 1.2	0.9 sutures Standard Deviation 1.3

SECONDARY outcome

Timeframe: Day 1, At delivery

Number of Participants to assess rate of SSI (any of superficial wound infection, deep wound infection, and endometritis)

Outcome measures

Measure	Standard Suture n=113 Participants Standard antimicrobial suture (vicryl) to close a C-section incision - control arm	Barbed Suture n=113 Participants Barbed suture type is STRATAFIX Symmetric PDS Plus Knotless Tissue to close a C-section incision
Number of Participants With Surgical Site Infections (SSI)	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 6 weeks

Population: not collected

Rate of SSI (any of superficial wound infection, deep wound infection, and endometritis)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1, At delivery and 2 weeks

Change in pain score at 2 weeks from baseline. Pain score from 0 to 10, with higher score indicating more pain.

Follow up pain assessment by a telephone screening 2 weeks following delivery.

Outcome measures

Measure	Standard Suture n=113 Participants Standard antimicrobial suture (vicryl) to close a C-section incision - control arm	Barbed Suture n=113 Participants Barbed suture type is STRATAFIX Symmetric PDS Plus Knotless Tissue to close a C-section incision
Change in Pain Score	3.1 score on a scale Standard Deviation 1.0	3.1 score on a scale Standard Deviation 1.0

Adverse Events

Standard Suture

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Barbed Suture

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Standard Suture n=113 participants at risk Standard antimicrobial suture (vicryl) to close a C-section incision - control arm	Barbed Suture n=113 participants at risk Barbed suture type is STRATAFIX Symmetric PDS Plus Knotless Tissue to close a C-section incision
Pregnancy, puerperium and perinatal conditions intrapartum hematoma	0.00% 0/113 • 1 day	0.88% 1/113 • 1 day

Additional Information

Nicola Tavella

Icahn School of Medicine at Mount Sinai

Phone: 212-241-3888

Email: nicola.tavella@mssm.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place