The Effect of Suturing Material on Scar Healing

Cesarean Section Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03968783
• Other study ID #: Cesarean suture study
• Status: Completed
• Phase: N/A
• Start date: May 27, 2019
• Est. completion date: January 27, 2020

Study information

• Verified date: February 2020
• Source: Bezmialem Vakif University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: January 27, 2020
• Est. primary completion date: July 27, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Section Complications
• Cesarean Wound Disruption
• Suture Related Complication
• Wound Heal
• Wounds and Injuries

Intervention

Other:
• Monofilament suture
1.0 monofilament synthetic absorbable suture for closure of the low transverse uterine incision
• Multifilament suture
1.0 multifilament synthetic absorbable suture for closure of the low transverse uterine incision

Locations

Country	Name	City	State
Turkey	Bezmialem Vakif University Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Bezmialem Vakif University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	blood loss	The hemoglobin and hematocrit values will be measured 24 hours after CS	24 hours
Secondary	additional sutures	number of additional hemostatic sutures	2 hours