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

Benha University

Status: Completed

Conditions: Cesarean Section Complications

Treatments: Other: Braded Suture material; Other: Multifilament vicryl suture material

Study type: Interventional

Funder types: Other

Identifiers

NCT07101952

RC 2-11-2024

Details and patient eligibility

About

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.

Enrollment: 250 patients

Sex: Female

Ages: 22 to 47 years old

Volunteers: Accepts Healthy Volunteers

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.

Exclusion criteria

• Patients who had multiple pregnancy;
• Patients who had fetus in abnormal lie or presentation;
• Patients who had previous repair of CSN;
• Patients with uncontrolled DM or hypertension;
• Patients who had maintained on immunosuppressive therapies, had autoimmune disorders;
• Patients who refused to sign the written consent were excluded from the study.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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250 participants in 2 patient groups

Vicryl group

Active Comparator group

Description:

In these patients, 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 conventional multifilament Vicryl.

Treatment:

Other: Multifilament vicryl suture material

Barbed absorbable synthetic monofilament group

Active Comparator group

Description:

In these patients, 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.

Treatment:

Other: Braded Suture material