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
| Type | Name | Description |
|---|---|---|
| OTHER | Braded 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. |
| OTHER | Multifilament 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. |
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.