Interest of 2-octyl-cyanoacrylate (Dermabond®) in Closing Surgical Incisions in Children Before Acquisition of Continence

Summary

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.

Conditions

• Inguinal Incisions

Interventions

DEVICE

cutaneous suture (Surjet)

cutaneous surjet suture

DEVICE

2-octyl-cyanoacrylate (Dermabond® glue)

the cutaneous suture is made with glue only

Sponsors & Collaborators

• Fondation Lenval

  collaborator OTHER

• Centre Hospitalier Régional Universitaire Montpellier

  collaborator OTHER

• Assistance Publique Hopitaux De Marseille

  collaborator OTHER

• Centre Hospitalier Universitaire de Nice

  lead OTHER

Principal Investigators

• Jean BREAUD, MD · Centre Hospitalier Universitaire de Nice

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Max Age

24 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-09-30

Primary Completion

2016-12-31

Completion

2018-06-30

Countries

• France

Study Locations