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Stratafix feasibility study

Stratafix feasibility study - Stratafix study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON40695
Enrollment
40
Registered
2014-05-13
Start date
2015-03-06
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sectio Caesarea Barbed sutures uterine closure

Interventions

Uterine closure with monofilament barbed suture, Stratafix, in comparison with the standard multifilament suture, Vicryl 1.0.

Sponsors

Sint Antonius Ziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - primary caesarean section - lower transverse uterine incision

Exclusion criteria

Exclusion criteria: - Repeat primary caesarean section - Previous lower abdominal or pelvic surgery - Gemelli (multiple pregnancy) - Instrumental assistance during caesarean section (assisted birth with forceps or vacuum cup) - Diabetes mellitus - Body Mass Index (BMI) > 35 - Placenta praevia - T/J uterine incision

Design outcomes

Primary

MeasureTime frame
Duration of uterine closure.

Secondary

MeasureTime frame
* Maternal blood loss during the procedure * Total duration of caesarean section * Necessity of extra haemostatic sutures * Postoperative pain * Use of analgetics * Continuing blood loss * Postoperative Hemoglobin level (development of anaemia) * Postoperative fever * Wound infection * Length of postoperative stay

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)