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| Name | Class |
|---|---|
| B.Braun Surgical SA | INDUSTRY |
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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%.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Novosyn® | Novosyn® used in patients undergoing uterus closure in cesarean section |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Novosyn® | Device | Novosyn® for uterus closure in patients undergoing cesarian section |
|
| 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:
| within the first 30 days ± 10 days following cesarean delivery. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
The study includes women giving birth by cesarian section.
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patients undergoing uterus closure in cesarean section
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| Name | Affiliation | Role |
|---|---|---|
| Carmen Bergos Sorolla, Dra. | Athaia Xarxa Assistencial Universitaria de Manresa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Athaia Xarxa Assistencial Universitaria de Manresa | Manresa | Barcelona | 08243 | Spain |
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| ID | Term |
|---|---|
| D007239 | Infections |
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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. |