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

NCT00909805 | Completed

• 1 other identifier: 08-PP-10
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 4

Brief 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

Keywords

dermabond glue; suture; children

Outcome Measures

Primary Outcomes (1)

• 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.

  J7-J10 and J+ 6 month

Secondary Outcomes (3)

• Re-evaluation of the HOLLANDER cosmetic score 6 month after wound-healing.

  J0, J7-J10 and J + 6 month

• Parental satisfaction: 0-100 numeric scale divided in 5 items.

  J0, J7-J10 and J + 6 month

• Nurse satisfaction : 0-100 numeric scale divided in 4 items.

  J0, J7-J10 and J + 6 month

Study Arms (2)

Cutaneous suture with glue

EXPERIMENTAL

Inguinal surgical incision closing using Dermabond® glue instead of cutaneous suture with surjet

Device: 2-octyl-cyanoacrylate (Dermabond® glue)

Conventional suture

ACTIVE COMPARATOR

Inguinal surgical incision closing with conventional cutaneous suture (surjet)

Device: cutaneous suture (Surjet)

Interventions

cutaneous suture (Surjet) DEVICE

cutaneous surjet suture

Conventional suture

2-octyl-cyanoacrylate (Dermabond® glue) DEVICE

the cutaneous suture is made with glue only

Also known as: 2-octyl-cyanoacrylate (Dermabond®)

Cutaneous suture with glue

Eligibility Criteria

• Age: Up to 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead
• Fondation Lenval: collaborator
• Centre Hospitalier Régional Universitaire Montpellier: collaborator
• Assistance Publique Hopitaux De Marseille: collaborator

Study Sites (4)

Centre Hospitalier Universitaire de Nice - Hôpital l'Archet2

Nice, Alpes Maritimes, 06000, France

Location

Fondation Lenval -Hôpital Pédiatrique

Nice, Alpes Maritimes, 06000, France

Location

Assistance Publique Hopitaux de Marseille - Hôpital Timone Enfants

Marseille, Bouches Du Rhône, 13000, France

Location

Centre Hospitalier Universitaire de Montpellier - Hôpital Lapeyronie

Montpellier, Hérault, 34000, France

Location

Study Officials

• Jean BREAUD, MD

  Centre Hospitalier Universitaire de Nice

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2009
• First Posted: May 29, 2009
• Study Start: September 1, 2009
• Primary Completion: December 1, 2016
• Study Completion: June 1, 2018
• Last Updated: July 23, 2018

Record last verified: 2018-02

Locations

FR (4)