Is there a reduction in uterine closure time and total operation time with the use of monofilament barbed suture, Stratafix?Is there less total blood loss during and after uterine closure?Is there a difference in postoperative recovery and admission…
ID
Source
Brief title
Condition
- Other condition
- Pregnancy, labour, delivery and postpartum conditions
Synonym
Health condition
Sectio Caesarea
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Duration of uterine closure.
Secondary outcome
* 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
Background summary
Barbed sutures have been a new development in suture material. We aim to find
the optimal suture material for uterine closure after a caesarean section. The
advantages of this barbed suture, Stratafix, are reduction of closure time (and
total operation time) due to absence of necessity of knots and self-anchoring
of the suture in the tissue. Thereby the self-anchoring suture will spread a
more equal tension across the surface for an optimal healing process without
any weak spots along the suture lining. Another advanatage is the fact the
Stratafix, barbed suture, is a monofilament. The standard suture used for
closure of the uterus during C-section is Vicryl, which is a multifilament. The
monofilament thread causes less microtrauma in the tissue and gives less chance
of woundinfection.
Study objective
Is there a reduction in uterine closure time and total operation time with the
use of monofilament barbed suture, Stratafix?
Is there less total blood loss during and after uterine closure?
Is there a difference in postoperative recovery and admission compared between
the Stratafix, monofilament barbed suture, and the Vicryl, multifilament
suture.
Study design
A randomized controlled feasibility study, single-blinded, monocenter.
Intervention
Uterine closure with monofilament barbed suture, Stratafix, in comparison with
the standard multifilament suture, Vicryl 1.0.
Study burden and risks
No risk or burden.
Koekoekslaan 1
Nieuwegein 3435 CM
NL
Koekoekslaan 1
Nieuwegein 3435 CM
NL
Listed location countries
Age
Inclusion criteria
- primary caesarean section
- lower transverse uterine incision
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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL48608.100.14 |