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Completed

NCT Number: NCT04220294

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.

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Key information

Conditions

Suture Line Infection

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Rambam healthcare campus

Haifa, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Subcutaneous tissue closure

Procedure

Subcutaneous tissue closure with 2-0 vicryl suture.

Primary outcomes

  1. Surgical site infection rate.

    Time frame: From admission up to 6 weeks postpartum.

    Surgical site infection rate.

Secondary outcomes

  1. 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.

  2. Rate of postoperative febrile morbidity.

    Time frame: From admission up to 6 weeks postpartum.

    Rate of maternal body temperature > 38°C.

  3. Rate of maternal fever.

    Time frame: From admission up to 6 weeks postpartum.

    Rate of maternal fever in degrees celsius.

  4. Duration of maternal fever.

    Time frame: From admission up to 6 weeks postpartum.

    Duration of maternal fever in days.

  5. 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.

  6. 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.

  7. Rate of bacteremia.

    Time frame: From admission up to 6 weeks postpartum.

    Rate of bacteremia.

  8. Rate of sepsis.

    Time frame: From admission up to 6 weeks postpartum.

    Rate of sepsis.

  9. Post-operative duration of hospitalization.

    Time frame: From admission up to 6 weeks postpartum.

    Post-operative duration of hospitalization in days.

  10. Postoperative pain.

    Time frame: From admission up to 6 weeks postpartum.

    Postoperative pain based on the visual analogue scale score ranging from 0-10.

  11. Rate of postoperative anemia.

    Time frame: From admission up to 6 weeks postpartum.

    Rate of a hemoglobin level of under 10 gr/dL

  12. 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)

  13. Breastfeeding rates.

    Time frame: From admission up to 6 weeks postpartum.

    Breastfeeding rates.

  14. 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

  15. Venous thromboembolism rates.

    Time frame: From admission up to 6 weeks postpartum.

    Venous thromboembolism rates.

  16. Rate of admission to intensive care unit.

    Time frame: From admission up to 6 weeks postpartum.

    Rates of admission to intensive care unit

  17. Maternal death rate

    Time frame: From admission up to 6 weeks postpartum.

    Maternal death rate.

Sponsors and collaborators

Lead sponsor

Rambam Health Care Campus

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jan 7, 2020
Registry last updated
Feb 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.