CompletedNot Applicable

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

Spain250 participantsStarted 2022-06-15

Plain-language 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%.

Who can participate

Age range18 Years

SexFEMALE

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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

What they're measuring

Rate of wound complications including post-cesarean section surgical site infections (SSIs)

Timeframe: within the first 30 days ± 10 days following cesarean delivery.

Trial details

NCT IDNCT05807633

SponsorAesculap AG

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2023-03-28

View on ClinicalTrials.gov More Cesarean Section Complications trials