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CompletedNCT03968783Updated Feb 11, 2020

The Effect of Suturing Material on Scar Healing

An interventional study of Monofilament suture and Multifilament suture in Wound Heal, Cesarean Section Complications and Cesarean Wound Disruption, sponsored by Bezmialem Vakif University. Completed at 1 site in Turkey. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-11.

Sponsored by Bezmialem Vakif University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
95
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Female
01

Study summary

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

Read the detailed description

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.

02

Conditions studied

  • Wound Heal
  • Cesarean Section Complications
  • Cesarean Wound Disruption
  • Suture Related Complication

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Keywords

  • cesarean section
  • scar heal
  • isthmocele
  • suture material
  • saline infusion sonography
03

In context

Wounds and Injuries

5,056 studies on the registry are indexed under Wounds and Injuries; 861 are open to participants now.

This study's enrollment of 95 is above the median of 52 across 3,239 interventional studies indexed under Wounds and Injuries.

Browse Wounds and Injuries studies →

Lead sponsor

Bezmialem Vakif University is the lead sponsor of 345 studies on the registry; 58 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • singleton pregnancy at term >37 weeks of gestational age

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
95 participants (actual)

Study arms

  • Experimental
    Monofilament suture

    continuous double-layer unlocked suturing with 1.0 monofilament synthetic absorbable suture

    Other: Monofilament suture

  • Active comparator
    Multifilament suture

    continuous double-layer unlocked suturing with 1.0 multifilament synthetic absorbable suture

    Other: Multifilament suture

Interventions

  • OtherMonofilament suture

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

  • OtherMultifilament suture

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

06

What researchers measure

Primary outcomes

  1. The healing ratio

    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.

    Time frame: 6 months

Secondary outcomes

  1. blood loss

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

    Time frame: 24 hours

  2. additional sutures

    number of additional hemostatic sutures

    Time frame: 2 hours

07

Study locations

1 site
  • Bezmialem Vakıf University Hospital
    Istanbul, 34093, Turkey
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 11, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03968783
Lead sponsor
Bezmialem Vakif University
Responsible party
Sponsor
First posted
May 30, 2019
Start date
May 27, 2019
Primary completion
Jul 27, 2019
Completion
Jan 27, 2020
Last update
Feb 11, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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