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Suture Material and C-Section Scar Niches: A Comparative Study

Influence of Suture Material Used for Cesarean Section Hysterotomy Closure on the Frequency of Scare Niche Formation

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07101952
Enrollment
250
Registered
2025-08-03
Start date
2024-07-12
Completion date
2024-10-25
Last updated
2025-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cesarean Section Complications

Brief summary

Defective healing of the uterine wound after a Cesarean section (CS) can lead to the formation of a CS niche (CSN). The specific technique used for closure and the type of suture material chosen are often overlooked factors that might contribute to the development of these niches. This study aimed to compare how frequently CSNs occur when the CS hysterotomy is closed using barbed suture material versus conventional vicryl suture material, with assessments primarily done via transvaginal ultrasound (TVS). The methodology involved closing the CS hysterotomy with a double-layer technique using unlocked continuous running sutures, where the first layer included the decidua and was overlapped by the second. Researchers evaluated several aspects, including the duration and feasibility of the hysterotomy closure, the grade of postoperative pain, and the length of hospital stay. Transvaginal ultrasounds were conducted monthly for three months post-operatively to monitor for CSN development and to gather descriptive measurements of any niches found. The absence of a CSN was considered an indicator of surgical success.

Interventions

OTHERBraded Suture material

The Cesarean section hysterotomy was closed using a double-layer technique involving unlocked continuous running sutures. The first layer incorporated the decidua, which was then overlapped by the second. The suture material used for this closure was barbed suture; which is absorbable synthetic monofilament polydioxanone with bars.

OTHERMultifilament vicryl suture material

The Cesarean section hysterotomy was closed using a double-layer technique involving unlocked continuous running sutures. The first layer incorporated the decidua, which was then overlapped by the second. The suture material used for this closure was barbed suture; which is absorbable synthetic monofilament polydioxanone with bars.

Sponsors

Benha University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
22 Years to 47 Years
Healthy volunteers
Yes

Inclusion criteria

* Patients planned for CS delivery either on emergency or elective bases for singleton fetus in cephalic presentation; * Patients were free of

Exclusion criteria

; * Patients who signed the written consent to participate in the study and attend the postpartum follow-up for three months.

Design outcomes

Primary

MeasureTime frameDescription
Surgical Success Rate in Relation to Suture Material3.5 MonthsThe comparison of the overall surgical success rate, defined by the absence of a Cesarean section niche (CSN), between groups using different suture materials, alongside the quantitative differences in descriptive metrics of any formed CSNs.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026