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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 :
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard suture | Active Comparator | Standard antimicrobial suture (vicryl) - control arm |
|
| Barbed suture | Experimental | Barbed suture type is STRATAFIX Symmetric PDS Plus Knotless Tissue |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Barbed suture | Device | to close a C-section incision |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Quantitative Blood Loss | Quantification of blood loss (QBL) | Day 1, At delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Time for Hysterotomy Closure | Time for hysterotomy closure | Day 1, At delivery |
| Number of Participants Who Need Additional Hemostatic Sutures | Day 1, At delivery |
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Inclusion Criteria:
Exclusion Criteria:
Pregnant women are the only subjects eligible for this study.
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| Name | Affiliation | Role |
|---|---|---|
| Calvin Lambert, MD | Icahn School of Medicine at Mount Sinai Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23596641 | Background | Pfuntner A, Wier LM, Stocks C. Most Frequent Procedures Performed in U.S. Hospitals, 2010. 2013 Feb. In: Healthcare Cost and Utilization Project (HCUP) Statistical Briefs [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2006 Feb-. Statistical Brief #149. Available from http://www.ncbi.nlm.nih.gov/books/NBK132428/ | |
| 24920976 |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Suture | Standard antimicrobial suture (vicryl) to close a C-section incision - control arm |
| FG001 | Barbed Suture | Barbed suture type is STRATAFIX Symmetric PDS Plus Knotless Tissue to close a C-section incision |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Suture | Standard antimicrobial suture (vicryl) to close a C-section incision - control arm |
| BG001 | Barbed Suture | Barbed suture type is STRATAFIX Symmetric PDS Plus Knotless Tissue to close a C-section incision |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Quantitative Blood Loss | Quantification of blood loss (QBL) | Posted | Mean | Standard Deviation | mL | Day 1, At delivery |
|
|
1 day
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Suture | Standard antimicrobial suture (vicryl) to close a C-section incision - control arm |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| intrapartum hematoma | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nicola Tavella | Icahn School of Medicine at Mount Sinai | 212-241-3888 | nicola.tavella@mssm.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 6, 2024 | Oct 10, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 15, 2023 | Oct 10, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D011098 | Polyglactin 910 |
| ID | Term |
|---|---|
| D011091 | Polyesters |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
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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.
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| Standard antimicrobial suture | Procedure | to close a C-section incision |
|
|
| Number of Hemostatic Sutures | Number of hemostatic sutures needed during procedure | Day 1, At delivery |
| 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) | Day 1, At delivery |
| Rate of Surgical Site Infections (SSI) | Rate of SSI (any of superficial wound infection, deep wound infection, and endometritis) | 6 weeks |
| 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. | Day 1, At delivery and 2 weeks |
| Greenberg JA, Goldman RH. Barbed suture: a review of the technology and clinical uses in obstetrics and gynecology. Rev Obstet Gynecol. 2013;6(3-4):107-15. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Participants |
|
|
| Secondary | Time for Hysterotomy Closure | Time for hysterotomy closure | Posted | Mean | Standard Deviation | seconds | Day 1, At delivery |
|
|
|
| Secondary | Number of Participants Who Need Additional Hemostatic Sutures | Posted | Count of Participants | Participants | Day 1, At delivery |
|
|
|
| Secondary | Number of Hemostatic Sutures | Number of hemostatic sutures needed during procedure | Posted | Mean | Standard Deviation | sutures | Day 1, At delivery |
|
|
|
| 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) | Posted | Count of Participants | Participants | Day 1, At delivery |
|
|
|
| Secondary | Rate of Surgical Site Infections (SSI) | Rate of SSI (any of superficial wound infection, deep wound infection, and endometritis) | not collected | Posted | 6 weeks |
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Day 1, At delivery and 2 weeks |
|
|
|
| 0 |
| 113 |
| 0 |
| 113 |
| 0 |
| 113 |
| EG001 | Barbed Suture | Barbed suture type is STRATAFIX Symmetric PDS Plus Knotless Tissue to close a C-section incision | 0 | 113 | 0 | 113 | 1 | 113 |
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| D008420 |
| Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |