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

Cesarean Section Complications Clinical Trial

— SCOTT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05807633
• Other study ID #: AAG-O-H-2128
• Status: Completed
• Start date: June 15, 2022
• Est. completion date: October 1, 2023

Study information

• Verified date: October 2023
• Source: Aesculap AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: October 1, 2023
• Est. primary completion date: March 28, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Section Complications
• Cesarean Section; Infection

Intervention

Device:
• Novosyn®
Novosyn® for uterus closure in patients undergoing cesarian section

Locations

Country	Name	City	State
Spain	Athaia Xarxa Assistencial Universitaria de Manresa	Manresa	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Aesculap AG	B.Braun Surgical SA

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	Incidence of reoperations/readmissions	Frequency of reoperations/readmissions	within the first 30 days ± 10 days following cesarean delivery.
Secondary	Length of Hospital Stay	Mean duration of hospital stay in patients undergoing cesarean section.	up to discharge (up to 10 days after surgery)
Secondary	Need for blood transfusion	Frequency of patients requiring blood transfusion	within the first 30 days ± 10 days following cesarean delivery.
Secondary	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.