Subcutaneous Continuous Versus Interrupted Sutures During Cesarean Section.

February 16, 2023 updated by: ROY LAUTERBACH MD, Rambam Health Care Campus

Surgical Site Infection Rate After Subcutaneous Continuous Versus Interrupted Sutures During Cesarean Section.

A comparison of the rate of surgical site infections after cesarean section depending on the type of suture used for subcutaneous closure-continuous versus interrupted.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Patients at term that are candidates for elective cesarean section will receive an explanation regarding the study and sign informed consent. Patients will then be divided randomly to one of 2 treatment groups based on the type of subcutaneous tissue closure:

  1. Interrupted sutures.
  2. Continuous sutures. Information regarding medical and obstetric history will be collected for each patient.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1238

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Haifa, Israel
        • Rambam Healthcare Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Pregnant women undergoing elective cesarean section.
  • Subcutaneous tissue layer>2 centimeter according to ultrasound.

Exclusion Criteria:

  • Non-elective CS.
  • Fever during the 48 hours prior to surgery.
  • Antibiotic treatment during the 48 hours prior to surgery.
  • Inability to give informed consent.
  • Preterm delivery (< 37 weeks' gestation).
  • Fetal death.
  • Known fetal anomalies or placental abnormalities.
  • Immunosuppressive conditions.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Interrupted sutures
Subcutaneous tissue closure by interrupted sutures.
Procedure: Subcutaneous tissue closure
Subcutaneous tissue closure with 2-0 vicryl suture.
Active Comparator: Continuous sutures
Subcutaneous tissue closure by continuous sutures.
Procedure: Subcutaneous tissue closure
Subcutaneous tissue closure with 2-0 vicryl suture.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Surgical site infection rate.
Time Frame: From admission up to 6 weeks postpartum.
Surgical site infection rate.
From admission up to 6 weeks postpartum.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Rate of re-admission due to surgical site infection.
Time Frame: From admission up to 6 weeks postpartum.
rate of re-admission within 6 weeks postpartum due to surgical site infection.
From admission up to 6 weeks postpartum.
Rate of postoperative febrile morbidity.
Time Frame: From admission up to 6 weeks postpartum.
Rate of maternal body temperature > 38°C.
From admission up to 6 weeks postpartum.
Rate of maternal fever.
Time Frame: From admission up to 6 weeks postpartum.
Rate of maternal fever in degrees celsius.
From admission up to 6 weeks postpartum.
Duration of maternal fever.
Time Frame: From admission up to 6 weeks postpartum.
Duration of maternal fever in days.
From admission up to 6 weeks postpartum.
Rate of antibiotic use for the treatment of surgical site infection.
Time Frame: From admission up to 6 weeks postpartum.
Rate of antibiotic use for the treatment of surgical site infection.
From admission up to 6 weeks postpartum.
Cesraean section-to-surgical site infection time interval.
Time Frame: From admission up to 6 weeks postpartum.
Cesraean section-to-surgical site infection time interval in days.
From admission up to 6 weeks postpartum.
Rate of bacteremia.
Time Frame: From admission up to 6 weeks postpartum.
Rate of bacteremia.
From admission up to 6 weeks postpartum.
Rate of sepsis.
Time Frame: From admission up to 6 weeks postpartum.
Rate of sepsis.
From admission up to 6 weeks postpartum.
Post-operative duration of hospitalization.
Time Frame: From admission up to 6 weeks postpartum.
Post-operative duration of hospitalization in days.
From admission up to 6 weeks postpartum.
Postoperative pain.
Time Frame: From admission up to 6 weeks postpartum.
Postoperative pain based on the visual analogue scale score ranging from 0-10.
From admission up to 6 weeks postpartum.
Rate of postoperative anemia.
Time Frame: From admission up to 6 weeks postpartum.
Rate of a hemoglobin level of under 10 gr/dL
From admission up to 6 weeks postpartum.
Blood transfusion rates.
Time Frame: From admission up to 6 weeks postpartum.
Blood transfusion rates (recommended to patients with a postpartum hemoglobin level of under 7 gr/dL or between 7-8 gr/dL if anemia related symptoms are present)
From admission up to 6 weeks postpartum.
Breastfeeding rates.
Time Frame: From admission up to 6 weeks postpartum.
Breastfeeding rates.
From admission up to 6 weeks postpartum.
rate of voiding problems.
Time Frame: From admission up to 6 weeks postpartum.
Rate of need for either intermittent catheterization or 24-hour foley insertion to void
From admission up to 6 weeks postpartum.
Venous thromboembolism rates.
Time Frame: From admission up to 6 weeks postpartum.
Venous thromboembolism rates.
From admission up to 6 weeks postpartum.
Rate of admission to intensive care unit.
Time Frame: From admission up to 6 weeks postpartum.
Rates of admission to intensive care unit
From admission up to 6 weeks postpartum.
Maternal death rate
Time Frame: From admission up to 6 weeks postpartum.
Maternal death rate.
From admission up to 6 weeks postpartum.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rambam Health Care Campus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 10, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 20, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 5, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 7, 2020

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 20, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 16, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 0621-19-RMB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings