Surgical Site InfectionPhase 4ASTCNCT03386240
Antibacterial-coated Sutures at Time of Cesarean
A Phase 4 study testing Vicryl-plus, monocryl-plus, PDS-plus (Triclosan-coated Sutures) and Vicryl, monocryl, PDS (not coated with triclosan) in people with Surgical Site Infection and Surgical Wound Infection, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Surgical Site Infection, Surgical Wound Infection, Cesarean Section; Infection
- What is being tested?
- Vicryl-plus, monocryl-plus, PDS-plus (Triclosan-coated Sutures) and Vicryl, monocryl, PDS (not coated with triclosan)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,169 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2018to 22 Nov 2024
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 18-50 years of age.
- Women ≥ 24 weeks' viable gestation.
- To undergo cesarean delivery.
Who cannot join
- Patient unwilling or unable to provide consent.
- No prenatal care or a non-resident patient who is unlikely to be followed-up after delivery.
- Immunosuppressed patients: i.e., taking systemic immunosuppressant or steroids (e.g. transplant patients; not including steroids for lung maturity), HIV with CD4<200, or other.
- Decision to use other than suture closure (e.g. secondary wound closure, mesh closure).
- Skin infection.
- Coagulopathy.
Show all 9Show fewer
- High likelihood of additional surgical procedure beyond cesarean (e.g. scheduled hysterectomy, bowel or adnexal surgery).
- Allergy to Triclosan.
- Incarcerated individuals.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Medical Branch in Galveston
Galveston, Texas, 77550
About this study
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.
Read the detailed description
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.
- Conditions
- Surgical Site Infection, Surgical Wound Infection, Cesarean Section; Infection, Cesarean Section Complications
- Being tested
- Vicryl-plus, monocryl-plus, PDS-plus (Triclosan-coated Sutures), Vicryl, monocryl, PDS (not coated with triclosan)
- Medical subject headings
- Surgical Wound Infection, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vicryl-plus, monocryl-plus, PDS-plus (Triclosan-coated Sutures)Drug
Also called Plus group
The intervention consists of using Plus group (Triclosan-coated Sutures)
Vicryl, monocryl, PDS (not coated with triclosan)Other
Also called Control group
Consists of equivalent sutures (not coated with triclosan) during cesarean delivery.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Vicryl-plus, monocryl-plus, PDS-plus (Triclosan-coated Sutures) |
| 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. Receives: Other: Vicryl, monocryl, PDS (not coated with triclosan) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 30 days following delivery
Participants With Surgical Site Infection
Number of participants who developed a surgical site infection (SSI) following cesarean delivery.
Measured: Within 30 days following delivery
Secondary outcomes (3)
Maternal Deaths
Number of Maternal Deaths.
Measured: 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.
Measured: 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.
Measured: Within 30 days following delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2017
- Study start9 Jan 2018
- Primary completion22 Nov 2024
- Study completion22 Nov 2024
Why it stopped: Futility
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Surgical Site InfectionStudies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blinded controlled clinical trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 1,169 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benjamin Bush, M.D., Principal investigator, University of Texas Medical Branch in Galveston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03386240
- Sponsor's protocol ID
- 17-0305
- Acronym
- ASTC
- Status last verified
- Jun 2026
- First submitted
- 21 Dec 2017
- Last updated
- 22 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibacterial-coated Sutures at Time of Cesarean
- ClinicalTrials.gov ID
- NCT03386240
- Acronym / sponsor ID
- ASTC / 17-0305
- Conditions
- Surgical Site Infection, Surgical Wound Infection, Cesarean Section; Infection, Cesarean Section Complications
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Futility
- Enrolment
- 1,169 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Study start
- 9 Jan 2018 (actual)
- Primary completion
- 22 Nov 2024 (actual)
- Study completion
- 22 Nov 2024 (actual)
- First posted
- 29 Dec 2017 (actual)
- Results
- Posted 22 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Double-blinded controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Vicryl-plus, monocryl-plus, PDS-plus (Triclosan-coated Sutures | Experimental | Drug: 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, monocryl, PDS (not coated with triclosan) | Placebo comparator | Other: 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18-50 years of age.
- Women ≥ 24 weeks' viable gestation.
- To undergo cesarean delivery.
Key exclusion criteria (9 listed)
- Patient unwilling or unable to provide consent.
- No prenatal care or a non-resident patient who is unlikely to be followed-up after delivery.
- Immunosuppressed patients: i.e., taking systemic immunosuppressant or steroids (e.g. transplant patients; not including steroids for lung maturity), HIV with CD4<200, or other.
- Decision to use other than suture closure (e.g. secondary wound closure, mesh closure).
- Skin infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vicryl-plus, monocryl-plus, PDS-plus (Triclosan-coated Sutures)Also: Plus groupThe intervention consists of using Plus group (Triclosan-coated Sutures) | Drug | Vicryl-plus, monocryl-plus, PDS-plus (Triclosan-coated Sutures |
| Vicryl, monocryl, PDS (not coated with triclosan)Also: Control groupConsists of equivalent sutures (not coated with triclosan) during cesarean delivery. | Other | Vicryl, monocryl, PDS (not coated with triclosan) |
Primary outcome
Participants With Endometritis, Wound Infection, or Other Post-Cesarean Infections
Time frame: Within 30 days following delivery
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.
Participants With Surgical Site Infection
Time frame: Within 30 days following delivery
Number of participants who developed a surgical site infection (SSI) following cesarean delivery.
3 secondary outcomes
Maternal Deaths
Time frame: Within 30 days following delivery
Participants With Wound Hematoma or Seroma
Time frame: Within 30 days following delivery
Participants With Puerperal Fever
Time frame: Within 30 days following delivery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin Bush, M.D. principal investigator
University of Texas Medical Branch in Galveston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vicryl-plus, monocryl-plus, PDS-plus (Triclosan-coated Sutures) and Vicryl, monocryl, PDS (not coated with triclosan) in people with Surgical Site Infection and Surgical Wound Infection, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants With Endometritis, Wound Infection, or Other Post-Cesarean Infections (time frame: Within 30 days following delivery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.