SCOTT: Performance of Novosyn® in Patients Undergoing Uterus Closure in Cesarean Section
Study Details
Study Description
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%.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Novosyn® Novosyn® used in patients undergoing uterus closure in cesarean section |
Device: Novosyn®
Novosyn® for uterus closure in patients undergoing cesarian section
|
Outcome Measures
Primary Outcome Measures
- Rate of wound complications including post-cesarean section surgical site infections (SSIs) [within the first 30 days ± 10 days following cesarean delivery.]
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.
Secondary Outcome Measures
- incidence of post-surgery complicated wound healing [within the first 30 days ± 10 days following cesarean delivery.]
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
- Incidence of reoperations/readmissions [within the first 30 days ± 10 days following cesarean delivery.]
Frequency of reoperations/readmissions
- Length of Hospital Stay [up to discharge (up to 10 days after surgery)]
Mean duration of hospital stay in patients undergoing cesarean section.
- Need for blood transfusion [within the first 30 days ± 10 days following cesarean delivery.]
Frequency of patients requiring blood transfusion
- Incidence of Adverse device effects (ADEs) [within the first 30 days ± 10 days following cesarean delivery.]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Female patients.
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Age ≥ 18 years
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Patients undergoing one of the following gynaecologic surgeries:
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scheduled (elective) cesarean section
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cesarean section in labour
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urgent cesarean section
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Use of Novosyn® following routine clinical practice.
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Patients with available electronic health records (EHR).
Exclusion Criteria:
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Any medical or psychological disorder that, in the investigator's opinion, may interfere with the patient's ability to comply with the study procedures.
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Participation in any clinical trial
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Athaia Xarxa Assistencial Universitaria de Manresa | Manresa | Barcelona | Spain | 08243 |
Sponsors and Collaborators
- Aesculap AG
- B.Braun Surgical SA
Investigators
- Principal Investigator: Carmen Bergos Sorolla, Dra., Athaia Xarxa Assistencial Universitaria de Manresa
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AAG-O-H-2128