Clinical trial NCT01546272: Medico-economic Evaluation of Subcutaneous Automatic Resorbable Staples Device
Official title: Medico-economic Evaluation of Subcutaneous Automatic Resorbable Staples Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: ENT Surgery
Gynecological Surgery
Plastic Surgery
Keywords: Subcutaneous resorbable sutures
Tolerance / effectiveness of subcutaneous suture
Reduced operative time and anesthesia time
Medico-economic evaluation
Accidental exposure to blood
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2012-03-07
Enrollment: 664
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A surgery made by an external incision requires to stitch the subcutaneous plans, usually performed using absorbable synthetic sutures hold on wire needle. This national, prospective, multicentric, and randomized study is devoted to estimate a technique of suture of the subcutaneous plans based on an implantable medical device delivering automatically absorbable staples. This particularly innovative technique lets to expect a tolerance and an efficiency at least equivalent to the reference technique (main objective). Moreover, this technique allows to anticipate a reduction of the duration of surgical procedure and anesthetic time while limiting the risks of blood wounds of the medical staff.The medical economic part of this study will check, from the point of view of the health care hospital, wether the technique is likely to reduce the costs and time consuming theater room procedures.


Eligibility criteria: Inclusion Criteria:

* Male or female aged 18 yrs to 75 yrs
* 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:

* Incision imposing a very angular or sinuous scar for which the use of the medical device is deemed unsuited (sinuous or bayonet incisions)
* 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

Primary outcomes:
measure: Overall PSAS score measured 3 months after the surgery
timeFrame: 3 months after the surgery
Secondary outcomes:
measure: Incremental cost-effectiveness ratio (ICER) or average cost of suture according to the procedure (wire or staple)
timeFrame: Day 0 (Procedure)
measure: Presence of scarring complications at day 8 (infection, dehiscence)
timeFrame: Day 8
measure: Measurement of suture, surgical and anesthetic times
timeFrame: Day 0 (procedure)
measure: Overall score of the PSAS scale
timeFrame: Months 3, 12 and 18
measure: Overall score of the OSAS scale
timeFrame: Months 3, 12 and 18
measure: Aesthetic quality of the scar
timeFrame: Month 18
measure: Quantification of accidental exposure to blood
timeFrame: During the surgery
Other outcomes:
Locations:
city: Nantes
country: France
facility: CHU de Nantes
state: Pays de la Loire
city: Amiens
country: France
facility: Amiens University Hospital
city: Angers
country: France
facility: Angers University Hospital
city: Besançon
country: France
facility: Besançon University Hospital
city: Bordeaux
country: France
facility: Bordeaux University Hospital "Centre FX. Michelet"
city: Brest
country: France
facility: Brest University Hospital "Hôpital du Morvan"
city: Caen
country: France
facility: Caen University Hospital "Hôpital de la Côte de Nacre"
city: Lille
country: France
facility: Lille University Hospital "Hôpital Roger Salengro"
city: Marseille
country: France
facility: "Assistance Publique des Hôpitaux de Marseille - La Conception"
city: Montpellier
country: France
facility: Montpellier University Hospital "Hôpital Gui de Chauliac"
city: Mulhouse
country: France
facility: Mulhouse Hospital "Emile Muller"
city: Nantes
country: France
facility: CHU Nantes
city: Nice
country: France
facility: "Institut de Cancérologie de Nice"
city: Paris
country: France
facility: "Assistance Publique des Hôpitaux de Paris - Hôpital Bichat"
city: Poitiers
country: France
facility: CHU Poitiers
city: Poitiers
country: France
facility: Poitiers University Hospital
city: Rennes
country: France
facility: Rennes University Hospital "CHU Pontchaillou"
city: Rennes
country: France
facility: Rennes University Hospital
city: Rouen
country: France
facility: Rouen University Hospital
city: Strasbourg
country: France
facility: Strasbourg University Hospital "Hôpital Hautepierre"
city: Toulouse
country: France
facility: "Institut Claudius Regaud"
city: Tours
country: France
facility: "Pôle Santé Léonard de Vinci"
city: Tours
country: France
facility: Pôle Santé Léonard de Vinci
city: Tours
country: France
facility: Tours University Hospital
Study officials:
affiliation: Nantes University Hospital
name: Olivier Malard, Professor
role: PRINCIPAL_INVESTIGATOR
References: