Performance of Novosyn® in Patients Undergoing Uterus Closure in Cesarean Section (SCOTT)

Aesculap

Status: Completed

Conditions: Cesarean Section Complications; Cesarean Section; Infection

Treatments: Device: Novosyn®

Study type: Observational

Funder types: Industry

Identifiers

NCT05807633

AAG-O-H-2128

Details and patient eligibility

About

The aim of this study is to collect clinical data on the use of Novosyn® applied for the uterus closure in cesarean section. Diverse parameters have been selected to assess that the safety and effectiveness of Novosyn® is comparable to published results, where the rate of SSIs in patients undergoing uterus closure in cesarean section was 10.6%.

Enrollment: 250 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female patients.
• Age ≥ 18 years
• Patients undergoing one of the following gynaecologic surgeries:
• scheduled (elective) cesarean section
• cesarean section in labour
• urgent cesarean section
• Use of Novosyn® following routine clinical practice.
• Patients with available electronic health records (EHR).

Exclusion criteria

• Any medical or psychological disorder that, in the investigator's opinion, may interfere with the patient's ability to comply with the study procedures.
• Participation in any clinical trial

Trial design

250 participants in 1 patient group

Novosyn®

Description:

Novosyn® used in patients undergoing uterus closure in cesarean section

Treatment:

Device: Novosyn®