Clinical Trials Directory

Trials / Completed

CompletedNCT07101952

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
Phase
N/A
Study type
Interventional
Enrollment
250 (actual)
Sponsor
Benha University · Academic / Other
Sex
Female
Age
22 Years – 47 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERBraded Suture materialThe 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 materialThe 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.

Timeline

Start date
2024-07-12
Primary completion
2024-09-15
Completion
2024-10-25
First posted
2025-08-03
Last updated
2025-08-03

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT07101952. Inclusion in this directory is not an endorsement.