Performance of Novosyn® in Patients Undergoing Uterus Closure in Cesarean Section

Completed

• Conditions: Cesarean Section Complications; Cesarean Section; Infection
• Interventions: Device: Novosyn®

• Registration Number: NCT05807633
• Lead Sponsor: Aesculap AG

Brief Summary

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%.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-15
• Primary Completion: 2023-03-28
• Study First Submitted: 2023-03-29
• Study First Submitted QC: 2023-03-29
• Study First Posted: 2023-04-11
• Status Verified: 2023-10
• Study Completion: 2023-10-01
• Last Update Submitted: 2023-10-16
• Last Update Posted: 2023-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 250

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Novosyn®	Novosyn®	Novosyn® used in patients undergoing uterus closure in cesarean section

Primary Outcome Measures

Name	Time	Method
Rate of wound complications including post-cesarean section surgical site infections (SSIs)	within the first 30 days ± 10 days following cesarean delivery.	Incidence of wound complications including post-cesarean section surgical site infections (SSI). The documented infections include the following: * Organ/space surgical site infections or endometritis; * Primary and secondary superficial incisional surgical site infections (involving the skin and subcutaneous tissue).; * Primary and secondary deep incisional surgical site infections (involving fascial and muscle layers).; * Severe complications of endometritis: septicemia, peritonitis, and septic thrombosis of the pelvic vessels.

Secondary Outcome Measures

Name	Time	Method
incidence of post-surgery complicated wound healing	within the first 30 days ± 10 days following cesarean delivery.	Frequency of patients with complicated wound healing. Wound healing assessment includes the healing progress, skin temperature, and the presence of oedema, seroma, and/or hematoma
Incidence of reoperations/readmissions	within the first 30 days ± 10 days following cesarean delivery.	Frequency of reoperations/readmissions
Length of Hospital Stay	up to discharge (up to 10 days after surgery)	Mean duration of hospital stay in patients undergoing cesarean section.
Need for blood transfusion	within the first 30 days ± 10 days following cesarean delivery.	Frequency of patients requiring blood transfusion
Incidence of Adverse device effects (ADEs)	within the first 30 days ± 10 days following cesarean delivery.	Frequency of patients with Adverse Device Effects (ADE), defined as any adverse event related to the use of an investigational medical device, including adverse events resulting from insufficient or inadequate Instructions for Use, deployment, implantation, installation, or operation, or any malfunction of the investigational medical device and any event resulting from use error or from intentional misuse of the investigational medical device.

Trial Locations

Locations (1)

Athaia Xarxa Assistencial Universitaria de Manresa; 🇪🇸 Manresa, Barcelona, Spain