The Effect of Suturing Material on Scar Healing

Not Applicable

Completed

• Conditions: Cesarean Section Complications; Suture Related Complication; Wound Heal; Cesarean Wound Disruption
• Interventions: Other: Monofilament suture; Other: Multifilament suture

• Registration Number: NCT03968783
• Lead Sponsor: Bezmialem Vakif University

Brief Summary

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

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.

Study Timeline

• Study Start: 2019-05-27
• Study First Submitted: 2019-05-28
• Study First Submitted QC: 2019-05-28
• Study First Posted: 2019-05-30
• Primary Completion: 2019-07-27
• Study Completion: 2020-01-27
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-10
• Last Update Posted: 2020-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 95

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Monofilament suture	Monofilament suture	continuous double-layer unlocked suturing with 1.0 monofilament synthetic absorbable suture
Multifilament suture	Multifilament suture	continuous double-layer unlocked suturing with 1.0 multifilament synthetic absorbable suture

Primary Outcome Measures

Name	Time	Method
The healing ratio	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 Outcome Measures

Name	Time	Method
blood loss	24 hours	The hemoglobin and hematocrit values will be measured 24 hours after CS
additional sutures	2 hours	number of additional hemostatic sutures

Trial Locations

Locations (1)

Bezmialem Vakıf University Hospital; 🇹🇷 Istanbul, Turkey