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Completed

NCT Number: NCT05807633

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

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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Key information

Conditions

Cesarean Section Complications Cesarean Section; Infection Infections

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Athaia Xarxa Assistencial Universitaria de Manresa

Manresa, Barcelona, 08243, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Novosyn®

Device

Novosyn® for uterus closure in patients undergoing cesarian section

Primary outcomes

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

    Time frame: 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 outcomes

  1. incidence of post-surgery complicated wound healing

    Time frame: 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

  2. Incidence of reoperations/readmissions

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

    Frequency of reoperations/readmissions

  3. Length of Hospital Stay

    Time frame: up to discharge (up to 10 days after surgery)

    Mean duration of hospital stay in patients undergoing cesarean section.

  4. Need for blood transfusion

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

    Frequency of patients requiring blood transfusion

  5. Incidence of Adverse device effects (ADEs)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Aesculap AG

Industry

Collaborators

  • B.Braun Surgical SA

Registry information

Official study title

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

Acronym: SCOTT

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 11, 2023
Registry last updated
Oct 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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