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

NCT05807633 | Completed

• 1 other identifier: AAG-O-H-2128
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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%.

Conditions

Cesarean Section Complications; Cesarean Section; Infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• incidence of post-surgery complicated wound healing

  within the first 30 days ± 10 days following cesarean delivery.

• Incidence of reoperations/readmissions

  within the first 30 days ± 10 days following cesarean delivery.

• Length of Hospital Stay

  up to discharge (up to 10 days after surgery)

• Need for blood transfusion

  within the first 30 days ± 10 days following cesarean delivery.

• Incidence of Adverse device effects (ADEs)

  within the first 30 days ± 10 days following cesarean delivery.

Study Arms (1)

Novosyn®

Novosyn® used in patients undergoing uterus closure in cesarean section

Device: Novosyn®

Interventions

Novosyn® DEVICE

Novosyn® for uterus closure in patients undergoing cesarian section

Novosyn®

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: The study includes women giving birth by cesarian section.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients undergoing uterus closure in cesarean section

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Aesculap AG: lead
• B.Braun Surgical SA: collaborator

Study Sites (1)

Athaia Xarxa Assistencial Universitaria de Manresa

Manresa, Barcelona, 08243, Spain

Location

MeSH Terms

Conditions

Infections

Study Officials

• Carmen Bergos Sorolla, Dra.

  Athaia Xarxa Assistencial Universitaria de Manresa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2023
• First Posted: April 11, 2023
• Study Start: June 15, 2022
• Primary Completion: March 28, 2023
• Study Completion: October 1, 2023
• Last Updated: October 17, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)