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

Study Overview
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Brief Summary
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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%.

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

Conditions
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Cesarean Section Complications, Cesarean Section; Infection

Intervention / Treatment
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* Device: Novosyn®


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Novosyn®<br>Novosyn® used in patients undergoing uterus closure in cesarean section | Device: Novosyn®<br>* Novosyn® for uterus closure in patients undergoing cesarian section<br>|

What is the study measuring?
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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. |