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

Assessment on the Performance of Novosyn® in Patients Undergoing Uterus Closure in Cesarean Section. A Retrospective, Monocenter, Observational Study in Daily Practice

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%.

Study Overview

• Status: Completed
• Conditions: Cesarean Section Complications; Cesarean Section; Infection
• Intervention / Treatment: Device: Novosyn®

• Study Type: Observational
• Enrollment (Actual): 250

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Manresa, Barcelona, Spain, 08243
      • Athaia Xarxa Assistencial Universitaria de Manresa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

patients undergoing uterus closure in cesarean section

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Novosyn®; Novosyn® used in patients undergoing uterus closure in cesarean section	Device: Novosyn®; Novosyn® for uterus closure in patients undergoing cesarian section

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of wound complications including post-cesarean section surgical site infections (SSIs)	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.	within the first 30 days ± 10 days following cesarean delivery.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of post-surgery complicated wound healing	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	within the first 30 days ± 10 days following cesarean delivery.
Incidence of reoperations/readmissions	Frequency of reoperations/readmissions	within the first 30 days ± 10 days following cesarean delivery.
Length of Hospital Stay	Mean duration of hospital stay in patients undergoing cesarean section.	up to discharge (up to 10 days after surgery)
Need for blood transfusion	Frequency of patients requiring blood transfusion	within the first 30 days ± 10 days following cesarean delivery.
Incidence of Adverse device effects (ADEs)	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.	within the first 30 days ± 10 days following cesarean delivery.

Collaborators and Investigators

• Sponsor: Aesculap AG
• Collaborators: B.Braun Surgical SA
• Investigators: Principal Investigator: Carmen Bergos Sorolla, Dra., Athaia Xarxa Assistencial Universitaria de Manresa

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2022
• Primary Completion (Actual): March 28, 2023
• Study Completion (Actual): October 1, 2023

Study Registration Dates

• First Submitted: March 29, 2023
• First Submitted That Met QC Criteria: March 29, 2023
• First Posted (Actual): April 11, 2023

Study Record Updates

• Last Update Posted (Actual): October 17, 2023
• Last Update Submitted That Met QC Criteria: October 16, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases
• Other Study ID Numbers: AAG-O-H-2128

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No