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.
| NCT number | NCT00909805 |
| Other study ID # | 08-PP-10 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | September 2009 |
| Est. completion date | June 2018 |
| Verified date | February 2018 |
| Source | Centre Hospitalier Universitaire de Nice |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 89 |
| Est. completion date | June 2018 |
| Est. primary completion date | December 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A to 24 Months |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Assistance Publique Hopitaux de Marseille - Hôpital Timone Enfants | Marseille | Bouches Du Rhône |
| France | Centre Hospitalier Universitaire de Montpellier - Hôpital Lapeyronie | Montpellier | Hérault |
| France | Centre Hospitalier Universitaire de Nice - Hôpital l'Archet2 | Nice | Alpes Maritimes |
| France | Fondation Lenval -Hôpital Pédiatrique | Nice | Alpes Maritimes |
| Lead Sponsor | Collaborator |
|---|---|
| Centre Hospitalier Universitaire de Nice | Assistance Publique Hopitaux De Marseille, Centre Hospitalier Régional Universitaire Montpellier, Fondation Lenval |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Re-evaluation of the HOLLANDER cosmetic score 6 month after wound-healing. | J0, J7-J10 and J + 6 month | ||
| Secondary | Parental satisfaction: 0-100 numeric scale divided in 5 items. | J0, J7-J10 and J + 6 month | ||
| Secondary | Nurse satisfaction : 0-100 numeric scale divided in 4 items. | J0, J7-J10 and J + 6 month |