Cesarean Section ComplicationsSCOTTNCT05807633
Performance of Novosyn® in Patients Undergoing Uterus Closure in Cesarean Section
An observational study of Cesarean Section Complications and Cesarean Section; Infection, run by Aesculap AG at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cesarean Section Complications, Cesarean Section; Infection
- What is being tested?
- Novosyn®
- Type of treatment
- Medical device
- How many people
- 250 participants
- Where
- 1 siteSpain
- Study dates
- 15 Jun 2022to 1 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: patients undergoing uterus closure in cesarean section
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Spain1 site
Athaia Xarxa Assistencial Universitaria de Manresa
Manresa, Barcelona, 08243
About this study
Official title: Assessment on the Performance of Novosyn® in Patients Undergoing Uterus Closure in Cesarean Section. A Retrospective, Monocenter, Observational Study in Daily Practice
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%.
- Being tested
- Novosyn®
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novosyn®Device
Novosyn® for uterus closure in patients undergoing cesarian section
| Study group | Role | What they receive |
|---|---|---|
| Novosyn® | Novosyn® used in patients undergoing uterus closure in cesarean section Receives: Device: Novosyn® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within the first 30 days ± 10 days following cesarean delivery.
Secondary outcomes (5)
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
Measured: within the first 30 days ± 10 days following cesarean delivery.
Incidence of reoperations/readmissions
Frequency of reoperations/readmissions
Measured: within the first 30 days ± 10 days following cesarean delivery.
Length of Hospital Stay
Mean duration of hospital stay in patients undergoing cesarean section.
Measured: up to discharge (up to 10 days after surgery)
Need for blood transfusion
Frequency of patients requiring blood transfusion
Measured: 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.
Measured: within the first 30 days ± 10 days following cesarean delivery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2023
- Study start15 Jun 2022
- Primary completion28 Mar 2023
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean Section ComplicationsStudies of the same condition, open and under way.
- More trials run by Aesculap AGThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aesculap AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- B.Braun Surgical SA
- Responsible party
- Sponsor
- Investigators
- Carmen Bergos Sorolla, Dra., Principal investigator, Athaia Xarxa Assistencial Universitaria de Manresa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05807633
- Sponsor's protocol ID
- AAG-O-H-2128
- Acronym
- SCOTT
- Status last verified
- Oct 2023
- First submitted
- 29 Mar 2023
- Last updated
- 17 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment on the Performance of Novosyn® in Patients Undergoing Uterus Closure in Cesarean Section. A Retrospective, Monocenter, Observational Study in Daily Practice
- ClinicalTrials.gov ID
- NCT05807633
- Acronym / sponsor ID
- SCOTT / AAG-O-H-2128
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Aesculap AGIndustry (pharma, biotech, devices)
- Collaborators
- B.Braun Surgical SA
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- 28 Mar 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 11 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Novosyn® | – | Device: Novosyn®Novosyn® used in patients undergoing uterus closure in cesarean section |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients undergoing uterus closure in cesarean section
Key inclusion criteria (8 listed)
- Female patients.
- Age ≥ 18 years
- Patients undergoing one of the following gynaecologic surgeries:
- scheduled (elective) cesarean section
- cesarean section in labour
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Novosyn®Novosyn® for uterus closure in patients undergoing cesarian section | Device | Novosyn® |
Primary outcome
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.
5 secondary outcomes
incidence of post-surgery complicated wound healing
Time frame: within the first 30 days ± 10 days following cesarean delivery.
Incidence of reoperations/readmissions
Time frame: within the first 30 days ± 10 days following cesarean delivery.
Length of Hospital Stay
Time frame: up to discharge (up to 10 days after surgery)
Need for blood transfusion
Time frame: within the first 30 days ± 10 days following cesarean delivery.
Incidence of Adverse device effects (ADEs)
Time frame: within the first 30 days ± 10 days following cesarean delivery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2023.
- Individual participant dataSharing planned: No
Related trials for Cesarean Section Complications
Not yet recruiting
Comparison of Effect of Two Different Doses of Intravenous Oxytocin on Patients Undergoing Elective Cesarean Section
Postpartum Hemorrhage, Uterine Atony
Not yet recruitingObservational study
Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
RecruitingPhase 1
Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
Pain, Postpartum Depression
Recruiting
Clinical Impact of Uterine Repair During Cesarean Section With Barbed Suture on the Incidence of Isthmocele
Isthmocele, Cesarean Scar Defect
Not yet recruiting
The Mepilex Cesarean Delivery Trial / MEPIDEL
Surgical Site Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carmen Bergos Sorolla, Dra. principal investigator
Athaia Xarxa Assistencial Universitaria de Manresa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cesarean Section Complications and Cesarean Section; Infection, run by Aesculap AG at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of wound complications including post-cesarean section surgical site infections (SSIs) (time frame: within the first 30 days ± 10 days following cesarean delivery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2023.