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The Effect of Suturing Material on Scar Healing

Primary Purpose

Wound Heal, Cesarean Section Complications, Cesarean Wound Disruption

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Monofilament suture
Multifilament suture
Sponsored by
Bezmialem Vakif University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Wound Heal focused on measuring cesarean section, scar heal, isthmocele, suture material, saline infusion sonography

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Bezmialem Vakıf University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Monofilament suture

Multifilament suture

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
May 28, 2019
Last Updated
February 10, 2020
Sponsor
Bezmialem Vakif University
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1. Study Identification

Unique Protocol Identification Number
NCT03968783
Brief Title
The Effect of Suturing Material on Scar Healing
Official Title
The Effect of Suturing Material on Scar Healing; a Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
May 27, 2019 (Actual)
Primary Completion Date
July 27, 2019 (Actual)
Study Completion Date
January 27, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bezmialem Vakif University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound Heal, Cesarean Section Complications, Cesarean Wound Disruption, Suture Related Complication
Keywords
cesarean section, scar heal, isthmocele, suture material, saline infusion sonography

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
95 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Monofilament suture
Arm Type
Experimental
Arm Description
continuous double-layer unlocked suturing with 1.0 monofilament synthetic absorbable suture
Arm Title
Multifilament suture
Arm Type
Active Comparator
Arm Description
continuous double-layer unlocked suturing with 1.0 multifilament synthetic absorbable suture
Intervention Type
Other
Intervention Name(s)
Monofilament suture
Intervention Description
1.0 monofilament synthetic absorbable suture for closure of the low transverse uterine incision
Intervention Type
Other
Intervention Name(s)
Multifilament suture
Intervention Description
1.0 multifilament synthetic absorbable suture for closure of the low transverse uterine incision
Primary Outcome Measure Information:
Title
The healing ratio
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
blood loss
Description
The hemoglobin and hematocrit values will be measured 24 hours after CS
Time Frame
24 hours
Title
additional sutures
Description
number of additional hemostatic sutures
Time Frame
2 hours

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Bezmialem Vakıf University Hospital
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey

12. IPD Sharing Statement

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The Effect of Suturing Material on Scar Healing

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