Objectives of this study are to determine whether Vicryl rapide ® or Monocryl ® is the optimal suture material for closing the skin in the suturing of an episiotomy. This will be done by determining pain and dyspareunia at several intervals after…
ID
Source
Brief title
Condition
- Postpartum and puerperal disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome is the pain score in sitting position (Visual Analogous Scale,
VAS) 10 days postpartum
Secondary outcome
Secundary outcomes are pain (VAS-score) 24 hours postpartum, dyspareunia 10
days postpartum and pain and dyspareunia 6 weeks and 3 months postpartum and
complications like wound dehiscence and infection.
Background summary
When an episiotomy has to be sutured following vaginal delivery, short term and
long term complaints of pain and dyspareunia are frequently reported. The
choice of suture material may well influence the severity and frequency of
complaints and the time intercourse is resumed.
In order to minimalise perineal complaints it is important to gain insight in
the optimal suture material.
Synthetic soluble suture materials have been proven to be superior to natural
and non-soluble materials. They exist as as braided, such as Vicryl ®/vicryl
rapide ®, and as monofilaments, such as Monocryl ®. Braided materials have a
larger surface area and give more friction when pulled through tissue, thereby
increasing the chances of infection and increasing tissue reaction to the
material. This could cause more perineal complaints when using Vicryl rapide ®
then using Monocryl ®.
Monocryl ® on the other hand dissolves slower (119 days) and retains traction
longer (25% after 14 days.). Vicryl rapide ® has the advantage of dissolving
within a short time and losing its traction (50% force after 5 days, 0 % after
14 days) and is completely dissolved after 42 days. This could lead to more
complaints when using Monocryl ®.
To determine if the differences in properties of the suturing materials have
clinical consequences such as differences in pain, dyspareunia and
complications further research needs to be done.
Study objective
Objectives of this study are to determine whether Vicryl rapide ® or Monocryl
® is the optimal suture material for closing the skin in the suturing of an
episiotomy. This will be done by determining pain and dyspareunia at several
intervals after the episiotomy.
Study design
single blinded randomized controlled trial
Intervention
Subcuticular stitching of the skin with Monocryl ® or Vicryl rapide ® when an
episiotomy has been made.
Study burden and risks
In this trial 2 stitching materials are being used with which extensive
experience exists for the closure of episiotomies. Knowlegde about the extent
of complaints in the healing process is lacking. Patients do not run additional
risks by participating in the trial. Patients will fill in the questionaires
which wil take four times several minutes.
Montessoriweg 1
3083 AN Rotterdam
NL
Montessoriweg 1
3083 AN Rotterdam
NL
Listed location countries
Age
Inclusion criteria
primiparous
uncomplicated episiotomy
Informed consent
Exclusion criteria
multiparous women
vaginal or perineal laceration other than extension of the vaginal part of the episiotomy.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL28922.101.10 |