Interest of 2-octyl-cyanoacrylate (Dermabond®) in Closing Surgical Incisions in Children Before Acquisition of Continence
Recruitment status was: Recruiting
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.
|Inguinal Incisions||Device: cutaneous suture (Surjet) Device: 2-octyl-cyanoacrylate (Dermabond® glue)|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Interest of 2-octyl-cyanoacrylate (Dermabond®) in Closing Surgical Incisions in Children Before Acquisition of Continence. Randomised, Prospective, Non-inferiority Study.|
- Adequate or suboptimal wound-healing rate defined by a HOLLANDER cosmetic score higher or equal to 5 at the end of the initial wound-healing period. [ Time Frame: J7-J10 and J+ 6 month ]
- Re-evaluation of the HOLLANDER cosmetic score 6 month after wound-healing. [ Time Frame: J0, J7-J10 and J + 6 month ]
- Parental satisfaction: 0-100 numeric scale divided in 5 items. [ Time Frame: J0, J7-J10 and J + 6 month ]
- Nurse satisfaction : 0-100 numeric scale divided in 4 items. [ Time Frame: J0, J7-J10 and J + 6 month ]
|Study Start Date:||September 2009|
|Estimated Study Completion Date:||September 2012|
|Primary Completion Date:||September 2009 (Final data collection date for primary outcome measure)|
Experimental: Cutaneous suture with glue
Inguinal surgical incision closing using Dermabond® glue instead of cutaneous suture with surjet
Device: 2-octyl-cyanoacrylate (Dermabond® glue)
the cutaneous suture is made with glue only
Other Name: 2-octyl-cyanoacrylate (Dermabond®)
Active Comparator: Conventional suture
Inguinal surgical incision closing with conventional cutaneous suture (surjet)
Device: cutaneous suture (Surjet)
cutaneous surjet suture
Please refer to this study by its ClinicalTrials.gov identifier: NCT00909805
|Contact: Cynthia CAILLONfirstname.lastname@example.org|
|Contact: Jocelyn RAPPemail@example.com|
|Centre Hospitalier Universitaire de Nice - Hôpital l'Archet2||Recruiting|
|Nice, Alpes maritimes, France, 06000|
|Contact: Jean BREAUD, MD 0492036128 firstname.lastname@example.org|
|Principal Investigator: Jean BREAUD, MD|
|Sub-Investigator: Florence BASTIANI, MD|
|Sub-Investigator: Jean-Yves KURZENNE, MD|
|Fondation Lenval -Hôpital Pédiatrique||Recruiting|
|Nice, Alpes maritimes, France, 06000|
|Contact: Jean-Stéphane VALLA, MD|
|Principal Investigator: Jean-Stéphane VALLA, MD|
|Sub-Investigator: Henri STEYAERT, MD|
|Assistance Publique Hopitaux de Marseille - Hôpital Timone Enfants||Recruiting|
|Marseille, Bouches du Rhône, France, 13000|
|Contact: Jean-Michel GUYS, MD|
|Principal Investigator: Jean-Michel GUYS, MD|
|Sub-Investigator: Hélène LE HORS, MD|
|Sub-Investigator: Géraldine HERY|
|Centre Hospitalier Universitaire de Montpellier - Hôpital Lapeyronie||Recruiting|
|Montpellier, Hérault, France, 34000|
|Contact: René-Benoit GALIFER, MD|
|Principal Investigator: René-Benoit GALIFER, MD|
|Sub-Investigator: Marie-Pierre GUYBAL, MD|
|Sub-Investigator: Dominique FORGES, MD|
|Sub-Investigator: Nicolas KHALFA, MD|
|Principal Investigator:||Jean BREAUD, MD||CHU de Nice|