The Effect of Suturing Material on Scar Healing

Study Overview
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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.

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.

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

Conditions
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Wound Heal, Cesarean Section Complications, Cesarean Wound Disruption, Suture Related Complication

Intervention / Treatment
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* Other: Monofilament suture
* Other: Multifilament suture


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cesarean section, scar heal, isthmocele, suture material, saline infusion sonography