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Completed

NCT Number: NCT03968783

The Effect of Suturing Material on Scar Healing

We want to compare the effects of 2 suture materials (monofilament and multifilament) on healing of the uterine scar after a cesarean delivery.

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Key information

Conditions

Wound Heal Cesarean Section Complications Cesarean Wound Disruption Suture Related Complication

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Bezmialem Vakıf University Hospital

Istanbul, 34093, Turkey (Türkiye)

About this study

Cesarean section (CS) is the most common type of obstetric surgery. When medically justified, CS can effectively prevent maternal and perinatal mortality and morbidity however, there are many short and long-term complications of CS. One of the most common complications is the CS scar defect. CS scar defects can develop after transverse incision of the lower uterine segment, which may result in prolonged postmenstrual bleeding, spotting, pelvic pain, and infertility. Suture material is an essential part of any major surgery, serving to hold opposing tissues together and accelerate the healing process, resulting in decreased scarring of the affected areas. We sought to evaluate the effects of different synthetic absorbable suture materials on cesarean scar defect formation.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • singleton pregnancy at term >37 weeks of gestational age

Exclusion criteria

  • history of previous cesarean section
  • history of previous uterine surgery
  • multiple gestation, placenta previa, polyhydramnious, fetal macrosomia
  • uterine atony history
  • gestational diabetes mellitus, gestational hypertension, preeclampsia, current or previous history of heart disease, liver, renal disorders or known coagulopath
  • active labor (with regular uterine contractions and cervical dilatation >4 cm

Treatment and study plan

Monofilament suture

Other

1.0 monofilament synthetic absorbable suture for closure of the low transverse uterine incision

Multifilament suture

Other

1.0 multifilament synthetic absorbable suture for closure of the low transverse uterine incision

Primary outcomes

  1. The healing ratio

    Time frame: 6 months

    Six months after the operation, the integrity of the cesarean scar at the uterine incision site will be assessed by hydrosonography. The healing ratio will be calculated as the thickness of the residual myometrium covering the defect, divided by the sum of the thickness of the residual myometrium covering the defect and the height of the wedge-shaped defect.

Secondary outcomes

  1. blood loss

    Time frame: 24 hours

    The hemoglobin and hematocrit values will be measured 24 hours after CS

  2. additional sutures

    Time frame: 2 hours

    number of additional hemostatic sutures

Sponsors and collaborators

Lead sponsor

Bezmialem Vakif University

Other

Registry information

Official study title

The Effect of Suturing Material on Scar Healing; a Randomised Controlled Trial

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
May 30, 2019
Registry last updated
Feb 11, 2020

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.

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