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Antibacterial-coated Sutures at Time of Cesarean (ASTC)

Primary Purpose

Surgical Site Infection, Surgical Wound Infection, Cesarean Section; Infection

Status

Recruiting

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Vicryl-plus, monocryl-plus, PDS-plus (Triclosan-coated Sutures)

Vicryl, monocryl, PDS (not coated with triclosan)

About this trial

This is an interventional treatment trial for Surgical Site Infection

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

18-50 years of age.
Women ≥ 24 weeks' viable gestation.
To undergo cesarean delivery.

Exclusion Criteria:

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.
High likelihood of additional surgical procedure beyond cesarean (e.g. scheduled hysterectomy, bowel or adnexal surgery).
Allergy to Triclosan.
Incarcerated individuals.

Sites / Locations

University of Texas Medical Branch in GalvestonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Vicryl-plus, monocryl-plus, PDS-plus (Triclosan-coated Sutures

Vicryl, monocryl, PDS (not coated with triclosan)

Arm Description

Use of Monocryl Plus, Vicryl Plus and PDS Plus Suture (Triclosan-coated sutures) will be used exclusively throughout the entire procedure.

Use of Monocryl, Vicryl and PDS Suture (equivalent uncoated sutures) will be used exclusively throughout the whole procedure.

Outcomes

Primary Outcome Measures

Composite of endometritis and/or wound infection and/or other post-cesarean infections

surgical site infection after cesarean

Secondary Outcome Measures

Full Information

NCT ID

NCT03386240

First Posted

December 21, 2017

Last Updated

September 15, 2023

Sponsor

The University of Texas Medical Branch, Galveston

1. Study Identification

Unique Protocol Identification Number

NCT03386240

Brief Title

Antibacterial-coated Sutures at Time of Cesarean

Acronym

ASTC

Official Title

Antibacterial-coated Sutures at Time of Cesarean

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 9, 2018 (Actual)

Primary Completion Date

January 30, 2024 (Anticipated)

Study Completion Date

January 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The University of Texas Medical Branch, Galveston

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Surgical Site Infection, Surgical Wound Infection, Cesarean Section; Infection, Cesarean Section Complications

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

Double-blinded controlled clinical trial

Masking

ParticipantCare ProviderInvestigator

Masking Description

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.

Allocation

Randomized

Enrollment

3374 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Vicryl-plus, monocryl-plus, PDS-plus (Triclosan-coated Sutures

Arm Type

Experimental

Arm Description

Use of Monocryl Plus, Vicryl Plus and PDS Plus Suture (Triclosan-coated sutures) will be used exclusively throughout the entire procedure.

Arm Title

Vicryl, monocryl, PDS (not coated with triclosan)

Arm Type

Placebo Comparator

Arm Description

Use of Monocryl, Vicryl and PDS Suture (equivalent uncoated sutures) will be used exclusively throughout the whole procedure.

Intervention Type

Drug

Intervention Name(s)

Vicryl-plus, monocryl-plus, PDS-plus (Triclosan-coated Sutures)

Other Intervention Name(s)

Plus group

Intervention Description

The intervention consists of using Plus group (Triclosan-coated Sutures)

Intervention Type

Other

Intervention Name(s)

Vicryl, monocryl, PDS (not coated with triclosan)

Other Intervention Name(s)

Control group

Intervention Description

Consists of equivalent sutures (not coated with triclosan) during cesarean delivery.

Primary Outcome Measure Information:

Title

Composite of endometritis and/or wound infection and/or other post-cesarean infections

Description

surgical site infection after cesarean

Time Frame

occurring within 30 days of delivery

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

Female admitted to labor and delivery

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 18-50 years of age. Women ≥ 24 weeks' viable gestation. To undergo cesarean delivery. Exclusion Criteria: 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. High likelihood of additional surgical procedure beyond cesarean (e.g. scheduled hysterectomy, bowel or adnexal surgery). Allergy to Triclosan. Incarcerated individuals.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Benjamin Bush, M.D.

Phone

(409)772-1011

babush@utmb.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Megan Shepherd, M.D.

Phone

4045636251

mcshephe@utmb.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Benjamin Bush, M.D.

Organizational Affiliation

University of Texas Medical Branch in Galveston

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Texas Medical Branch in Galveston

City

Galveston

State/Province

Texas

ZIP/Postal Code

77550

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Benjamin Bush, M.D.

Phone

409-772-1011

babush@utmb.edu

First Name & Middle Initial & Last Name & Degree

Megan Shepherd, M.D.

Phone

(409)772-0982

mcshephe@utmb.edu

12. IPD Sharing Statement

Plan to Share IPD

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Antibacterial-coated Sutures at Time of Cesarean

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