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%.
Study Type
OBSERVATIONAL
Enrollment
250
Novosyn® for uterus closure in patients undergoing cesarian section
Athaia Xarxa Assistencial Universitaria de Manresa
Manresa, Barcelona, Spain
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.
Time frame: within the first 30 days ± 10 days following cesarean delivery.
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
Time frame: within the first 30 days ± 10 days following cesarean delivery.
Incidence of reoperations/readmissions
Frequency of reoperations/readmissions
Time frame: within the first 30 days ± 10 days following cesarean delivery.
Length of Hospital Stay
Mean duration of hospital stay in patients undergoing cesarean section.
Time frame: up to discharge (up to 10 days after surgery)
Need for blood transfusion
Frequency of patients requiring blood transfusion
Time frame: 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.
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Time frame: within the first 30 days ± 10 days following cesarean delivery.