Medico-economic Evaluation of Subcutaneous Automatic Resorbable Staples Device

Gynecological Surgery Clinical Trial

— S2CARA  

Official title:

Medico-economic Evaluation of Subcutaneous Automatic Resorbable Staples Device

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01546272
• Other study ID #: RC11_0147
• Status: Completed
• Phase: Phase 3
• First received: February 21, 2012
• Last updated: March 7, 2016
• Start date: March 2012
• Est. completion date: November 2015

Study information

• Verified date: March 2016
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 664
• Est. completion date: November 2015
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• ENT Surgery
• Gynecological Surgery
• Plastic Surgery

Intervention

Device:
• Insorb resorbable staples
Subcutanous suture using resorbable staples
• Monocryl resorbable wire
Subcutanous suture using resorbable wire

Locations

Country	Name	City	State
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 de Nantes	Nantes	Pays de la Loire
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	Rennes
France	Rennes University Hospital "CHU Pontchaillou"	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

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall PSAS score measured 3 months after the surgery	Overall PSAS score measured 3 months after the surgery(PSAS : "Patient Scar Assessment Scale")	3 months after the surgery	No
Secondary	Incremental cost-effectiveness ratio (ICER) or average cost of suture according to the procedure (wire or staple)		Day 0 (Procedure)	No
Secondary	Presence of scarring complications at day 8 (infection, dehiscence)		Day 8	Yes
Secondary	Measurement of suture, surgical and anesthetic times		Day 0 (procedure)	No
Secondary	Overall score of the PSAS scale	The tolerance will be assessed by the overall score of the PSAS scale (Patient Scar Assessment Scale)	Months 3, 12 and 18	No
Secondary	Overall score of the OSAS scale	The scar quality will be assessed by the overall score of the OSAS scale (Observer Scar Assessment Scale)	Months 3, 12 and 18	No
Secondary	Aesthetic quality of the scar	The aesthetic quality of the scar will be assessed by the patient and a physician (not the surgeon) by a score range from 0 to 10	Month 18	No
Secondary	Quantification of accidental exposure to blood		During the surgery	Yes