Wound HealNCT03968783
The Effect of Suturing Material on Scar Healing
A study testing Monofilament suture and Multifilament suture in people with Wound Heal and Cesarean Section Complications, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Wound Heal, Cesarean Section Complications, Cesarean Wound Disruption
- What is being tested?
- Monofilament suture and Multifilament suture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 May 2019to 27 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- singleton pregnancy at term >37 weeks of gestational age
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bezmialem Vakıf University Hospital
Istanbul, 34093
About this study
Official title: 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.
Read the 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.
- Conditions
- Wound Heal, Cesarean Section Complications, Cesarean Wound Disruption, Suture Related Complication
- Being tested
- Monofilament suture, Multifilament suture
- Keywords
- cesarean section, scar heal, isthmocele, suture material, saline infusion sonography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monofilament sutureOther
1.0 monofilament synthetic absorbable suture for closure of the low transverse uterine incision
Multifilament sutureOther
1.0 multifilament synthetic absorbable suture for closure of the low transverse uterine incision
| Study group | Role | What they receive |
|---|---|---|
| Monofilament suture | Experimental | continuous double-layer unlocked suturing with 1.0 monofilament synthetic absorbable suture Receives: Other: Monofilament suture |
| Multifilament suture | Active comparator | continuous double-layer unlocked suturing with 1.0 multifilament synthetic absorbable suture Receives: Other: Multifilament suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (2)
blood loss
The hemoglobin and hematocrit values will be measured 24 hours after CS
Measured: 24 hours
additional sutures
number of additional hemostatic sutures
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2019
- Study start27 May 2019
- Primary completion27 Jul 2019
- Study completion27 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound HealStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03968783
- Sponsor's protocol ID
- Cesarean suture study
- Status last verified
- Feb 2020
- First submitted
- 28 May 2019
- Last updated
- 11 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Suturing Material on Scar Healing; a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03968783
- Acronym / sponsor ID
- Cesarean suture study
- Conditions
- Wound Heal, Cesarean Section Complications, Cesarean Wound Disruption, Suture Related Complication
- Keywords
- cesarean section, scar heal, isthmocele, suture material, saline infusion sonography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 27 May 2019 (actual)
- Primary completion
- 27 Jul 2019 (actual)
- Study completion
- 27 Jan 2020 (actual)
- First posted
- 30 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Monofilament suture | Experimental | Other: Monofilament suturecontinuous double-layer unlocked suturing with 1.0 monofilament synthetic absorbable suture |
| Multifilament suture | Active comparator | Other: Multifilament suturecontinuous double-layer unlocked suturing with 1.0 multifilament synthetic absorbable suture |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- singleton pregnancy at term >37 weeks of gestational age
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Monofilament suture1.0 monofilament synthetic absorbable suture for closure of the low transverse uterine incision | Other | Monofilament suture |
| Multifilament suture1.0 multifilament synthetic absorbable suture for closure of the low transverse uterine incision | Other | Multifilament suture |
Primary outcome
The healing ratio
Time frame: 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.
2 secondary outcomes
blood loss
Time frame: 24 hours
additional sutures
Time frame: 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Monofilament suture and Multifilament suture in people with Wound Heal and Cesarean Section Complications, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The healing ratio (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2020.