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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05807633
Other study ID # AAG-O-H-2128
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


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.
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