Status:
COMPLETED
Interest of 2-octyl-cyanoacrylate (Dermabond®) in Closing Surgical Incisions in Children Before Acquisition of Continence
Lead Sponsor:
Centre Hospitalier Universitaire de Nice
Collaborating Sponsors:
Fondation Lenval
Centre Hospitalier Régional Universitaire Montpellier
Conditions:
Inguinal Incisions
Eligibility:
All Genders
Up to 24 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2018
Estimated Enrollment :
89 Patients enrolled
Trial Details
Trial ID
NCT00909805
Start Date
September 1 2009
End Date
June 1 2018
Last Update
July 23 2018
Active Locations (4)
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1
Centre Hospitalier Universitaire de Nice - Hôpital l'Archet2
Nice, Alpes Maritimes, France, 06000
2
Fondation Lenval -Hôpital Pédiatrique
Nice, Alpes Maritimes, France, 06000
3
Assistance Publique Hopitaux de Marseille - Hôpital Timone Enfants
Marseille, Bouches Du Rhône, France, 13000
4
Centre Hospitalier Universitaire de Montpellier - Hôpital Lapeyronie
Montpellier, Hérault, France, 34000