Subcutaneous Continuous Versus Interrupted Sutures During Cesarean Section.

NCT ID: NCT04220294

Last Updated: 2023-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1238 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-10

Study Completion Date

2022-10-20

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Suture Line Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Interrupted sutures

Subcutaneous tissue closure by interrupted sutures.

Group Type ACTIVE_COMPARATOR

Subcutaneous tissue closure

Intervention Type PROCEDURE

Subcutaneous tissue closure with 2-0 vicryl suture.

Continuous sutures

Subcutaneous tissue closure by continuous sutures.

Group Type ACTIVE_COMPARATOR

Subcutaneous tissue closure

Intervention Type PROCEDURE

Subcutaneous tissue closure with 2-0 vicryl suture.

Interventions

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Subcutaneous tissue closure

Subcutaneous tissue closure with 2-0 vicryl suture.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Rambam Health Care Campus

OTHER

Sponsor Role lead

Responsible Party

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ROY LAUTERBACH MD

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Roy Lauterbach, MD

Role: PRINCIPAL_INVESTIGATOR

Rambam Healthcare Campus

Locations

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Rambam healthcare campus

Haifa, , Israel

Site Status

Countries

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Israel

Other Identifiers

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0621-19-RMB

Identifier Type: -

Identifier Source: org_study_id

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