Medico-economic Evaluation of Subcutaneous Automatic Resorbable Staples Device
NCT ID: NCT01546272
Last Updated: 2016-03-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
664 participants
INTERVENTIONAL
2012-03-31
2015-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Resorbable staples
Suture using Insorb Resorbable staples
Insorb resorbable staples
Subcutanous suture using resorbable staples
Resorbable wires
Suture using Monocryl resorbable wire
Monocryl resorbable wire
Subcutanous suture using resorbable wire
Interventions
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Insorb resorbable staples
Subcutanous suture using resorbable staples
Monocryl resorbable wire
Subcutanous suture using resorbable wire
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient supported for a scheduled surgery :
For abdominoplasty, cervicotomy or suprapubic surgery With a open incision necessary for operative exposition of 10 cm or more with a straight or curved surgery incision
* Person covered by Health Insurance
* ECOG Performance Status 0 or 1
* Patient's informed and written consent
Exclusion Criteria
* Known history of intolerance to any component of the medical device
* Immunocompromised patients or undergoing a long term treatment by corticosteroids or immunosuppressants
* Known or anticipated presence of a skin infection (due to the infected skin condition, or because of underlying surgery conducted in infected territory or likely to be)
* Dermatological disease or skin treatment in progress
* History of radiation therapy on the surgical site or antimitotic treatment in progress
* Pregnancy at the time of suture
* Patients simultaneously included in another treatment protocol
* Patients under legal guardianship
* Non French speaking patients, refusing or unfit for the monitoring proposed in the study
18 Years
75 Years
ALL
No
Sponsors
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Nantes University Hospital
OTHER
Responsible Party
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Principal Investigators
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Olivier Malard, Professor
Role: PRINCIPAL_INVESTIGATOR
Nantes University Hospital
Locations
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CHU de Nantes
Nantes, Pays de la Loire Region, France
Amiens University Hospital
Amiens, , France
Angers University Hospital
Angers, , France
Besançon University Hospital
Besançon, , France
Bordeaux University Hospital "Centre FX. Michelet"
Bordeaux, , France
Brest University Hospital "Hôpital du Morvan"
Brest, , France
Caen University Hospital "Hôpital de la Côte de Nacre"
Caen, , France
Lille University Hospital "Hôpital Roger Salengro"
Lille, , France
"Assistance Publique des Hôpitaux de Marseille - La Conception"
Marseille, , France
Montpellier University Hospital "Hôpital Gui de Chauliac"
Montpellier, , France
Mulhouse Hospital "Emile Muller"
Mulhouse, , France
CHU Nantes
Nantes, , France
"Institut de Cancérologie de Nice"
Nice, , France
"Assistance Publique des Hôpitaux de Paris - Hôpital Bichat"
Paris, , France
CHU Poitiers
Poitiers, , France
Poitiers University Hospital
Poitiers, , France
Rennes University Hospital "CHU Pontchaillou"
Rennes, , France
Rennes University Hospital
Rennes, , France
Rouen University Hospital
Rouen, , France
Strasbourg University Hospital "Hôpital Hautepierre"
Strasbourg, , France
"Institut Claudius Regaud"
Toulouse, , France
"Pôle Santé Léonard de Vinci"
Tours, , France
Pôle Santé Léonard de Vinci
Tours, , France
Tours University Hospital
Tours, , France
Countries
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Other Identifiers
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RC11_0147
Identifier Type: -
Identifier Source: org_study_id
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