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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Centre Hospitalier Universitaire de Nice.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Fondation Lenval
Centre Hospitalier Régional Universitaire Montpellier
Assistance Publique Hopitaux De Marseille
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT00909805
First received: May 28, 2009
Last updated: March 23, 2012
Last verified: March 2010
  Purpose

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.

Condition Intervention
Inguinal Incisions
Device: cutaneous suture (Surjet)
Device: 2-octyl-cyanoacrylate (Dermabond® glue)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
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.

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nice:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Re-evaluation of the HOLLANDER cosmetic score 6 month after wound-healing. [ Time Frame: J0, J7-J10 and J + 6 month ] [ Designated as safety issue: No ]
  • Parental satisfaction: 0-100 numeric scale divided in 5 items. [ Time Frame: J0, J7-J10 and J + 6 month ] [ Designated as safety issue: No ]
  • Nurse satisfaction : 0-100 numeric scale divided in 4 items. [ Time Frame: J0, J7-J10 and J + 6 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 248
Study Start Date: September 2009
Estimated Study Completion Date: September 2012
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   up to 24 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children less than 24 months old
  • Continuous nappies wearing for non-acquisition of continence
  • Need of a surgical intervention which entry way is an inguinal incision in the inguinal fold (POTTS incision) for the following indications:

    • inguinal hernia
    • testicular ectopy
    • hydrocele
    • chord cyst
  • Surgical incision smaller than 5 cm
  • Informed consent form signed by both parents or by the legal representative
  • Patient affiliated to French national health and pensions organization

Exclusion Criteria:

  • Chronic or acute dermatological affection that can hamper wound-healing (atopic pathology, infectious pathology…)
  • General affection that can hamper wound-healing (chronic denutrition)
  • Cutaneous infection at the incision site
  • Scar in the concerned region
  • Medical history of wound-healing trouble
  • Digestive pathology causing chronic or acute diarrhea
  • Allergy to one of the used compounds (glue, string, wound dressing)
  • Operative indication set in emergency with immediate surgery
  • Non-acceptance of the protocol, refusal to participate to the study by one of the parents or the legal representative
  • Impossibility of doing the follow up of the child, in accordance with the pre-established rules of the protocol
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00909805

Contacts
Contact: Cynthia CAILLON 0492034589 giran.c@chu-nice.fr
Contact: Jocelyn RAPP 0492034254 rapp.j@chu-nice.fr

Locations
France
Centre Hospitalier Universitaire de Nice - Hôpital l'Archet2 Recruiting
Nice, Alpes maritimes, France, 06000
Contact: Jean BREAUD, MD    0492036128    breaud.j@chu-nice.fr   
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         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Fondation Lenval
Centre Hospitalier Régional Universitaire Montpellier
Assistance Publique Hopitaux De Marseille
Investigators
Principal Investigator: Jean BREAUD, MD CHU de Nice
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT00909805     History of Changes
Other Study ID Numbers: 08-PP-10
Study First Received: May 28, 2009
Last Updated: March 23, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Institutional Ethical Committee
France: French Data Protection Authority

Keywords provided by Centre Hospitalier Universitaire de Nice:
dermabond glue
suture
children

ClinicalTrials.gov processed this record on April 14, 2014