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Futility
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Abdominal closure with antibacterial-coated sutures has been shown to reduce wound infections after a number of surgical procedures, but none of the previous trials included cesarean delivery. Our objective is to determine whether use of antibacterial-coated sutures reduces surgical site infection (SSI) after cesarean delivery.
A review of 18 studies demonstrated a significant benefit of antimicrobial coated sutures in reducing SSI (RCTs: OR 0.72; 95% CI 0.59-0.88; observational studies: OR 0.58; 95% CI 0.40-0.83). As there are no clinical trials focusing on cesarean delivery, and because the risk factors and pathogenesis for post-cesarean SSI may not mirror other procedures, further data is needed before generalizing the WHO recommendations to cesarean procedures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vicryl-plus, monocryl-plus, PDS-plus (Triclosan-coated Sutures | Experimental | Use of Monocryl Plus, Vicryl Plus and PDS Plus Suture (Triclosan-coated sutures) will be used exclusively throughout the entire procedure. |
|
| Vicryl, monocryl, PDS (not coated with triclosan) | Placebo Comparator | Use of Monocryl, Vicryl and PDS Suture (equivalent uncoated sutures) will be used exclusively throughout the whole procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vicryl-plus, monocryl-plus, PDS-plus (Triclosan-coated Sutures) | Drug | The intervention consists of using Plus group (Triclosan-coated Sutures) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Participants With Endometritis, Wound Infection, or Other Post-Cesarean Infections | 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. | Within 30 days following delivery |
| Participants With Surgical Site Infection | Number of participants who developed a surgical site infection (SSI) following cesarean delivery. | Within 30 days following delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Maternal Deaths | Number of Maternal Deaths. | Within 30 days following delivery |
| Participants With Wound Hematoma or Seroma | Number 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. |
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Inclusion Criteria:
Exclusion Criteria:
Female admitted to labor and delivery
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| Name | Affiliation | Role |
|---|---|---|
| Benjamin Bush, M.D. | University of Texas Medical Branch in Galveston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Medical Branch in Galveston | Galveston | Texas | 77550 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Dec 13, 2023 |
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Double-blinded controlled clinical trial
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A confidential computer-generated simple randomization scheme will be prepared and provided on an ongoing basis. A randomization log will be used to track the randomization process. Patients will be masked to the suture material. Both suture types look similar. Patient, surgeons, and staff ascertaining the outcomes will be masked for the suture type.
|
| Vicryl, monocryl, PDS (not coated with triclosan) | Other | Consists of equivalent sutures (not coated with triclosan) during cesarean delivery. |
|
|
| Within 30 days following delivery |
| Participants With Puerperal Fever | Number 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. | Within 30 days following delivery |
| FG001 |
| 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. |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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) |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | Participants With Endometritis, Wound Infection, or Other Post-Cesarean Infections | 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. | Posted | Count of Participants | Participants | Within 30 days following delivery |
|
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Participants With Surgical Site Infection | Number of participants who developed a surgical site infection (SSI) following cesarean delivery. | Posted | Count of Participants | Participants | Within 30 days following delivery |
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Maternal Deaths | Number of Maternal Deaths. | Posted | Count of Participants | Participants | Within 30 days following delivery |
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| Secondary | Participants With Wound Hematoma or Seroma | Number 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. | Posted | Count of Participants | Participants | Within 30 days following delivery |
|
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| Secondary | Participants With Puerperal Fever | Number 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. | Posted | Count of Participants | Participants | Within 30 days following delivery |
|
|
30 days following delivery
1 AE during the study period was reported. We are unaware of any other adverse events during the study period.
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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 | 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) | 0 | 585 | 0 | 585 | 1 | 585 |
| EG001 | 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. | 0 | 584 | 0 | 584 | 0 | 584 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Unanticipated Problem | Renal and urinary disorders | Systematic Assessment | Cystotomy occurring at the time of cesarean section. |
|
The study began in January 2018 and underwent multiple Principal Investigator (PI) transitions. The data provided represents the information currently available to the study team.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gayle Olson Koutrouvelis, MD, MPH | UTMB | 409-747-4905 | golson@utmb.edu |
| Mar 21, 2025 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| D007239 | Infections |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D044382 | Population Groups |
| D011098 | Polyglactin 910 |
| C095495 | glycolide E-caprolactone copolymer |
| D014260 | Triclosan |
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D003710 | Demography |
| D011154 | Population Characteristics |
| D011091 | Polyesters |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| D010647 | Phenyl Ethers |
| D004987 | Ethers |
| D009930 | Organic Chemicals |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
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| >=65 years |
|
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Other Post-Cesarean Infections |
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