The Effect of Suturing Material on Scar Healing

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

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

Study Overview

• Status: Completed
• Conditions: Cesarean Section Complications; Wound Heal; Suture Related Complication; Cesarean Wound Disruption
• Intervention / Treatment: Other: Monofilament suture; Other: Multifilament suture

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 Type: Interventional
• Enrollment (Actual): 95
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34093
    • Bezmialem Vakıf University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Monofilament suture; continuous double-layer unlocked suturing with 1.0 monofilament synthetic absorbable suture	Other: Monofilament suture; 1.0 monofilament synthetic absorbable suture for closure of the low transverse uterine incision
Active Comparator: Multifilament suture; continuous double-layer unlocked suturing with 1.0 multifilament synthetic absorbable suture	Other: Multifilament suture; 1.0 multifilament synthetic absorbable suture for closure of the low transverse uterine incision

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
blood loss	The hemoglobin and hematocrit values will be measured 24 hours after CS	24 hours
additional sutures	number of additional hemostatic sutures	2 hours

Collaborators and Investigators

• Sponsor: Bezmialem Vakif University

Study record dates

Study Major Dates

• Study Start (Actual): May 27, 2019
• Primary Completion (Actual): July 27, 2019
• Study Completion (Actual): January 27, 2020

Study Registration Dates

• First Submitted: May 28, 2019
• First Submitted That Met QC Criteria: May 28, 2019
• First Posted (Actual): May 30, 2019

Study Record Updates

• Last Update Posted (Actual): February 11, 2020
• Last Update Submitted That Met QC Criteria: February 10, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: cesarean section; suture material; isthmocele; scar heal; saline infusion sonography
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: Cesarean suture study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No