Inguinal Incisions Clinical Trial
Official title:
Interest of 2-octyl-cyanoacrylate (Dermabond®) in Closing Surgical Incisions in Children Before Acquisition of Continence. Randomised, Prospective, Non-inferiority Study.
Inguinal incisions are the most frequent incisions used in children before the acquisition of
continence (180 incisions per year for the Pediatric Surgery Department in Nice CHU).
However, healing of those wounds can be made hard because of soiling induced by urine and/or
stool, which is unavoidable in case of wearing nappies.
Nowadays, in order to overcome a possible contamination of the surgical wound, post-surgery
wound dressing is protected by the application of a waterproof band aid (like Tegaderm®)
during wound-healing (evaluated to a mean of 7 days). When the band aid is soiled, a nurse
changes it, causing unpleasantness in low age children (whose epidermal fragility is well
known), and sometimes parents worry.
Moreover, those occlusive wound dressings avoid any control of the surgical wound during
healing phase.
At the end of the wound-healing time, wound dressings are removed, causing discomfort for
children and necessity of a qualified nurse staff at visit times.
Cutaneous use glues, introduced in surgery more than 10 years ago, allow making waterproof
and transparent sutures, with a firmness equivalent to a 2/0 string suture (cutaneous suture
in children is made with 5/0) and has its own local antiseptic properties. It does not need
to be covered by any wound dressing during wound-healing phase. Moreover, cosmetic results
for the 2-octyl-cyanoacrylate in the adult and children series (without any precise age
distinction) seem to be equivalent to conventional sutures. Finally, its application goes
with time saving (in preoperative and during wound-healing phase) and increases comfort for
patients.
The aim of this study is to evaluate the efficiency of cutaneous use glue Dermabond®
(2-octyl-cyanoacrylate) in surgical inguinal incisions sutures in children before the
acquisition of continence, by a non-inferiority randomized multicentric prospective study.
Two patient groups will be studied, the sutures of one control group will be made with a
conventional technique (intradermic surjet surgical suture), and one patient group will be
sutured with 2-octyl-cyanoacrylate. The principal evaluation criteria is the suture quality
(short- and long-term cosmetic aspect) evaluated by the surgeon.
Two secondary criteria will be studied :
- Parental satisfaction
- Ease of clinical nursing management Each studied criteria will be evaluated by a numeric
score.
n/a