Hysterotomy
Conditions
Keywords
Barbed suture, Blood loss, Hysterotomy, Cesarean section
Brief summary
This is a randomized controlled trial. The purpose of this study is to see if patients whose uterine incision (hysterotomy), at the time of scheduled cesarean section, is closed with barbed suture, have less blood loss compared to women whose incision is closed with the standard suture (vicryl). The primary outcome is quantification of blood loss (QBL). Secondary outcomes include time for hysterotomy closure, need for additional hemostatic sutures, rate of endometritis, use of hemostatic agents, and differences in pain which will be assessed by a telephone screening in the days following delivery. Study participation will last 1 year and will include the following research procedures : 1. Randomization to barbed suture vs. standard suture 2. Collection of data for primary and secondary outcomes 3. Telephone survey 2 weeks following the procedure to assess pain, bowel/bladder habits, and evidence of wound infection. The barbed suture is approved by the FDA for use in soft tissue approximation and this is not an off-label usage.
Detailed description
This is a prospective, randomized controlled trial (RCT) evaluating whether using a barbed suture to close a C-section incision can reduce blood loss. Patients undergoing C-section will be randomized with equal allocation to a barbed suture or a standard antimicrobial suture. The primary outcome is quantification of blood loss (QBL). Differences between the groups will be assessed using a 0.05 level Wilcoxon rank-sum test. Secondary outcomes include time for hysterotomy closure, need for additional hemostatic sutures, rate of endometritis/SSI (superficial wound infection, deep wound infection, and endometritis) within 6 weeks postpartum, use of hemostatic agents, and differences in pain which will be assessed by a telephone screening in the days following delivery.
Interventions
DEVICEBarbed suture
to close a C-section incision
PROCEDUREStandard antimicrobial suture
to close a C-section incision
Sponsors
Icahn School of Medicine at Mount Sinai
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Patients will be randomly assigned to either the treatment arm or control arm of the study prior to commencement of the cesarean section and following informed consent. Allocation will be concealed to all researchers/providers until this point. The patients will be randomly allocated by block randomization. Generation of random sequence will be done by independent personnel, usually a statistician, who is not going to be involved in the conduct of the RCT. The access to this sequence should be restricted to only a few individuals who absolutely need to have access.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
* All patients undergoing a scheduled primary cesarean section at Mount Sinai Hospital * age 18-64.
Exclusion criteria
* Multifetal gestations * Placenta previas * Pre-term patients * Patients with prior uterine incisions or a coagulopathy (DIC, Von Willebrands Disease, etc) * Patients undergoing an unplanned or emergency cesarean section
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quantitative Blood Loss | Day 1, At delivery | Quantification of blood loss (QBL) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Need Additional Hemostatic Sutures | Day 1, At delivery | — |
| Number of Hemostatic Sutures | Day 1, At delivery | Number of hemostatic sutures needed during procedure |
| Time for Hysterotomy Closure | Day 1, At delivery | Time for hysterotomy closure |
| Rate of Surgical Site Infections (SSI) | 6 weeks | Rate of SSI (any of superficial wound infection, deep wound infection, and endometritis) |
| Change in Pain Score | 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. |
| Number of Participants With Surgical Site Infections (SSI) | Day 1, At delivery | Number of Participants to assess rate of SSI (any of superficial wound infection, deep wound infection, and endometritis) |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Standard Suture Standard antimicrobial suture (vicryl) to close a C-section incision - control arm | 113 |
| Barbed Suture Barbed suture type is STRATAFIX Symmetric PDS Plus Knotless Tissue to close a C-section incision | 113 |
| Total | 226 |
Baseline characteristics
| Characteristic | Barbed Suture | Total | Standard Suture |
|---|---|---|---|
| Age, Continuous | 35.9 years STANDARD_DEVIATION 6.1 | 35.3 years STANDARD_DEVIATION 5.6 | 34.7 years STANDARD_DEVIATION 5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 26 Participants | 47 Participants | 21 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 81 Participants | 169 Participants | 88 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 6 Participants | 10 Participants | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 15 Participants | 29 Participants | 14 Participants |
| Race (NIH/OMB) Black or African American | 15 Participants | 30 Participants | 15 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 35 Participants | 62 Participants | 27 Participants |
| Race (NIH/OMB) White | 48 Participants | 105 Participants | 57 Participants |
| Sex: Female, Male Female | 113 Participants | 226 Participants | 113 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 113 | 0 / 113 |
| other Total, other adverse events | 0 / 113 | 1 / 113 |
| serious Total, serious adverse events | 0 / 113 | 0 / 113 |
Outcome results
Primary
Quantitative Blood Loss
Quantification of blood loss (QBL)
Time frame: Day 1, At delivery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Suture | Quantitative Blood Loss | 641.8 mL | Standard Deviation 300.2 |
| Barbed Suture | Quantitative Blood Loss | 596.5 mL | Standard Deviation 283.2 |
Secondary
Change in Pain Score
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.
Time frame: Day 1, At delivery and 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Suture | Change in Pain Score | 3.1 score on a scale | Standard Deviation 1 |
| Barbed Suture | Change in Pain Score | 3.1 score on a scale | Standard Deviation 1 |
Secondary
Number of Hemostatic Sutures
Number of hemostatic sutures needed during procedure
Time frame: Day 1, At delivery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Suture | Number of Hemostatic Sutures | 1.1 sutures | Standard Deviation 1.2 |
| Barbed Suture | Number of Hemostatic Sutures | 0.9 sutures | Standard Deviation 1.3 |
Secondary
Number of Participants Who Need Additional Hemostatic Sutures
Time frame: Day 1, At delivery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Suture | Number of Participants Who Need Additional Hemostatic Sutures | 50 Participants |
| Barbed Suture | Number of Participants Who Need Additional Hemostatic Sutures | 67 Participants |
Secondary
Number of Participants With Surgical Site Infections (SSI)
Number of Participants to assess rate of SSI (any of superficial wound infection, deep wound infection, and endometritis)
Time frame: Day 1, At delivery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Suture | Number of Participants With Surgical Site Infections (SSI) | 0 Participants |
| Barbed Suture | Number of Participants With Surgical Site Infections (SSI) | 0 Participants |
Secondary
Rate of Surgical Site Infections (SSI)
Rate of SSI (any of superficial wound infection, deep wound infection, and endometritis)
Time frame: 6 weeks
Population: not collected
Secondary
Time for Hysterotomy Closure
Time for hysterotomy closure
Time frame: Day 1, At delivery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Suture | Time for Hysterotomy Closure | 326.3 seconds | Standard Deviation 122.1 |
| Barbed Suture | Time for Hysterotomy Closure | 277.9 seconds | Standard Deviation 97.3 |