NCT04220294

Completed

Subcutaneous Continuous Versus Interrupted Sutures During Ce...

Rambam Health Care Campus Source

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Other study identifiers

Sponsor study identifier

0621-19-RMB

Study Type

interventional

Actual enrollment (reported)

1,238

Locations

1 country

Sites

1

Timeline

Study Start

January 10, 2020

Actual (reported)

Primary Completion

April 30, 2022

Actual (reported)

Study Completion

October 20, 2022

Actual (reported)

Brief Summary

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 1,238 participants
Study completion date: October 20, 2022
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
January 5, 2020
Actual (reported)
First Posted
January 7, 2020
Actual (reported)
Study Start
January 10, 2020
Actual (reported)
Primary Completion
April 30, 2022
Actual (reported)
Study Completion
October 20, 2022
Actual (reported)

Last Updated: February 21, 2023
Status Verified: February 2023
Last Update Submitted: February 16, 2023

Conditions

Suture Line Infection

Outcome Measures

Primary Outcomes (1)

Surgical site infection rate.
Surgical site infection rate.
From admission up to 6 weeks postpartum.

Secondary Outcomes (17)

Rate of re-admission due to surgical site infection.
From admission up to 6 weeks postpartum.
Rate of postoperative febrile morbidity.
From admission up to 6 weeks postpartum.
Rate of maternal fever.
From admission up to 6 weeks postpartum.
Duration of maternal fever.
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.
+12 more secondary outcomes

Study Arms (2)

Interrupted sutures

ACTIVE COMPARATOR

Subcutaneous tissue closure by interrupted sutures.

Procedure: Subcutaneous tissue closure

Continuous sutures

ACTIVE COMPARATOR

Subcutaneous tissue closure by continuous sutures.

Procedure: Subcutaneous tissue closure

Interventions

Subcutaneous tissue closureProcedure

Subcutaneous tissue closure with 2-0 vicryl suture.

Continuous suturesInterrupted sutures

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 45 Years

Sexfemale(Gender-based eligibility)

Gender Eligibility DetailsFemale

Healthy VolunteersNo

Age GroupsAdult (18-64)

You may qualify if:

Pregnant women undergoing elective cesarean section.

Sponsors & Collaborators

Rambam Health Care Campus
Otherlead

Study Sites (1)

Rambam healthcare campus

Haifa, Israel

Study Officials

Roy Lauterbach, MD
Rambam Healthcare Campus
PRINCIPAL INVESTIGATOR

Enrollment

1,238 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: PARTICIPANT
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Principal investigator

Study Record Dates

First Submitted

January 5, 2020

First Posted

January 7, 2020

Study Start

January 10, 2020

Actual (reported)

Subcutaneous tissue layer\>2 centimeter according to ultrasound.

You may not qualify if:

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.

Contact the study team to confirm eligibility.

Primary Completion

April 30, 2022

Actual (reported)

Study Completion

October 20, 2022

Actual (reported)

Last Updated

February 21, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing: Will not share

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT04220294
Data provider: ClinicalTrials.gov
Source updated: 2023-02-21
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:40:39 UTC

Locations

IL(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (17)

Study Arms (2)

Interrupted sutures

Continuous sutures

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations