Comparative Analysis of Subcuticular Suture Materials in Cesarean Section
NCT Number: NCT06543329
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cesarean Wound Disruption With Postnatal Complication
Interventions: PROCEDURE: polyglactin 910|PROCEDURE: poliglecaprone 25|PROCEDURE: polypropylene|PROCEDURE: polyester
Sponsor: Cairo University
Collaborators: Kafrelsheikh University
Sex: FEMALE
Age: ADULT
Enrollment: 300
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-08-01
Completion Date: 2025-08-30
Locations: faculty of medicine, Kasr el ainy hospital, Cairo university, Cairo, 11562, Egypt

Summary:
1.1. Background and Rationale Cesarean section is one of the most common surgical procedures performed worldwide. The choice of suture material for closing the skin incision is crucial, as it can influence wound healing, the risk of wound complications, and the cosmetic outcome. Subcuticular suturing, a technique where the suture is placed just under the skin, is favored for its aesthetic benefits and reduced risk of infection. However, the type of suture material used can significantly impact these outcomes. This study aims to provide a comparative analysis of various subcuticular suture materials used in cesarean sections, focusing on wound complications and incision outcomes.

1.2. Objective of the Study The objective of this study is to compare the incidence of wound complications and the quality of incision outcomes associated with different subcuticular suture materials used in cesarean sections. By doing so, the investigators aim to identify the most effective suture material for minimizing wound complications and optimizing cosmetic results.

Primary Outcome Measures: the rate of any documented wound complication during the first six weeks postpartum, This measure tracks the incidence of wound complications within six weeks postpartum, including infection, dehiscence, seroma, hematoma, ecchymosis, pus, delayed healing, and secondary suture needs.

Measurement Tools:

Clinical examinations during follow-up visits Patient self-reports Review of medical records

Assessment Procedure:

Patients will undergo follow-up visits at 2, 4, and 6 weeks postpartum. Complications will be documented through clinical exams, patient reports, and medical record reviews.

Calculation:

The rate is calculated as the number of patients with any wound complication divided by the total number of patients, expressed as a percentage., 6 weeks
Secondary Outcome Measures: cosmetics satisfaction, This measure assesses the cosmetic appearance of surgical wounds post-abdominal myomectomy.

Measurement Tool:

A standardized cosmetic appearance scale will be used, such as the Patient and Observer Scar Assessment Scale (POSAS).

Assessment Procedure:

Evaluations will be conducted at follow-up visits (2, 4, and 6 weeks postpartum) by both the patient and a clinician.

Parameters Assessed:

Scar color, texture, and overall appearance Patient satisfaction with the cosmetic outcome

Calculation:

Scores from the POSAS will be averaged to determine the overall cosmetic appearance rating., 6 weeks