The Effect of Suturing Material on Scar Healing

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

95 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-27

Study Completion Date

2020-01-27

Brief Summary

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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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Detailed Description

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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.

Conditions

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Wound Heal Cesarean Section Complications Cesarean Wound Disruption Suture Related Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Monofilament suture

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

Group Type EXPERIMENTAL

Monofilament suture

Intervention Type OTHER

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

Multifilament suture

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

Group Type ACTIVE_COMPARATOR

Multifilament suture

Intervention Type OTHER

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

Interventions

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Monofilament suture

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

Intervention Type OTHER

Multifilament suture

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes