NCT04220294

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,238

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 5, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 7, 2020

Completed
3 days until next milestone

Study Start

First participant enrolled

January 10, 2020

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2022

Completed
Last Updated

February 21, 2023

Status Verified

February 1, 2023

Enrollment Period

2.3 years

First QC Date

January 5, 2020

Last Update Submit

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

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.
  • 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.

Sponsors & Collaborators

Study Sites (1)

Rambam healthcare campus

Haifa, Israel

Location

Study Officials

  • Roy Lauterbach, MD

    Rambam Healthcare Campus

    PRINCIPAL INVESTIGATOR

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

Primary Completion

April 30, 2022

Study Completion

October 20, 2022

Last Updated

February 21, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)