search
Back to results

Subcutaneous Continuous Versus Interrupted Sutures During Cesarean Section.

Primary Purpose

Suture Line Infection

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Subcutaneous tissue closure
Sponsored by
Rambam Health Care Campus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Suture Line Infection

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Pregnant women undergoing elective cesarean section.
  • Pregnant women undergoing emergent cesarean section.

Exclusion Criteria:

  • Fever prior to surgery.
  • Antibiotic use prior to surgery.

Sites / Locations

  • Rambam healthcare campus

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Interrupted sutures

Continuous sutures

Arm Description

Subcutaneous tissue closure by interrupted sutures.

Subcutaneous tissue closure by continuous sutures.

Outcomes

Primary Outcome Measures

Surgical site infection rate.
Surgical site infection rate.

Secondary Outcome Measures

Rate of re-admission due to surgical site infection.
rate of re-admission within 6 weeks postpartum due to surgical site infection.
Rate of postoperative febrile morbidity.
Rate of maternal body temperature > 38°C.
Rate of maternal fever.
Rate of maternal fever in degrees celsius.
Duration of maternal fever.
Duration of maternal fever in days.
Rate of antibiotic use for the treatment of surgical site infection.
Rate of antibiotic use for the treatment of surgical site infection.
Cesraean section-to-surgical site infection time interval.
Cesraean section-to-surgical site infection time interval in days.
Rate of bacteremia.
Rate of bacteremia.
Rate of sepsis.
Rate of sepsis.
Post-operative duration of hospitalization.
Post-operative duration of hospitalization in days.
Postoperative pain.
Postoperative pain based on the visual analogue scale score ranging from 0-10.
Rate of postoperative anemia.
Rate of a hemoglobin level of under 10 gr/dL
Blood transfusion rates.
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)
Breastfeeding rates.
Breastfeeding rates.
rate of voiding problems.
Rate of need for either intermittent catheterization or 24-hour foley insertion to void
Venous thromboembolism rates.
Venous thromboembolism rates.
Rate of admission to intensive care unit.
Rates of admission to intensive care unit
Maternal death rate
Maternal death rate.

Full Information

First Posted
January 5, 2020
Last Updated
February 16, 2023
Sponsor
Rambam Health Care Campus
search

1. Study Identification

Unique Protocol Identification Number
NCT04220294
Brief Title
Subcutaneous Continuous Versus Interrupted Sutures During Cesarean Section.
Official Title
Surgical Site Infection Rate After Subcutaneous Continuous Versus Interrupted Sutures During Cesarean Section.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
January 10, 2020 (Actual)
Primary Completion Date
April 30, 2022 (Actual)
Study Completion Date
October 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rambam Health Care Campus

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
1238 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interrupted sutures
Arm Type
Active Comparator
Arm Description
Subcutaneous tissue closure by interrupted sutures.
Arm Title
Continuous sutures
Arm Type
Active Comparator
Arm Description
Subcutaneous tissue closure by continuous sutures.
Intervention Type
Procedure
Intervention Name(s)
Subcutaneous tissue closure
Intervention Description
Subcutaneous tissue closure with 2-0 vicryl suture.
Primary Outcome Measure Information:
Title
Surgical site infection rate.
Description
Surgical site infection rate.
Time Frame
From admission up to 6 weeks postpartum.
Secondary Outcome Measure Information:
Title
Rate of re-admission due to surgical site infection.
Description
rate of re-admission within 6 weeks postpartum due to surgical site infection.
Time Frame
From admission up to 6 weeks postpartum.
Title
Rate of postoperative febrile morbidity.
Description
Rate of maternal body temperature > 38°C.
Time Frame
From admission up to 6 weeks postpartum.
Title
Rate of maternal fever.
Description
Rate of maternal fever in degrees celsius.
Time Frame
From admission up to 6 weeks postpartum.
Title
Duration of maternal fever.
Description
Duration of maternal fever in days.
Time Frame
From admission up to 6 weeks postpartum.
Title
Rate of antibiotic use for the treatment of surgical site infection.
Description
Rate of antibiotic use for the treatment of surgical site infection.
Time Frame
From admission up to 6 weeks postpartum.
Title
Cesraean section-to-surgical site infection time interval.
Description
Cesraean section-to-surgical site infection time interval in days.
Time Frame
From admission up to 6 weeks postpartum.
Title
Rate of bacteremia.
Description
Rate of bacteremia.
Time Frame
From admission up to 6 weeks postpartum.
Title
Rate of sepsis.
Description
Rate of sepsis.
Time Frame
From admission up to 6 weeks postpartum.
Title
Post-operative duration of hospitalization.
Description
Post-operative duration of hospitalization in days.
Time Frame
From admission up to 6 weeks postpartum.
Title
Postoperative pain.
Description
Postoperative pain based on the visual analogue scale score ranging from 0-10.
Time Frame
From admission up to 6 weeks postpartum.
Title
Rate of postoperative anemia.
Description
Rate of a hemoglobin level of under 10 gr/dL
Time Frame
From admission up to 6 weeks postpartum.
Title
Blood transfusion rates.
Description
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)
Time Frame
From admission up to 6 weeks postpartum.
Title
Breastfeeding rates.
Description
Breastfeeding rates.
Time Frame
From admission up to 6 weeks postpartum.
Title
rate of voiding problems.
Description
Rate of need for either intermittent catheterization or 24-hour foley insertion to void
Time Frame
From admission up to 6 weeks postpartum.
Title
Venous thromboembolism rates.
Description
Venous thromboembolism rates.
Time Frame
From admission up to 6 weeks postpartum.
Title
Rate of admission to intensive care unit.
Description
Rates of admission to intensive care unit
Time Frame
From admission up to 6 weeks postpartum.
Title
Maternal death rate
Description
Maternal death rate.
Time Frame
From admission up to 6 weeks postpartum.

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roy Lauterbach, MD
Organizational Affiliation
Rambam Healthcare Campus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rambam healthcare campus
City
Haifa
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Subcutaneous Continuous Versus Interrupted Sutures During Cesarean Section.

We'll reach out to this number within 24 hrs