Medico-economic Evaluation of Subcutaneous Automatic Resorbable Staples Device (S2CARA)

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.

Study Overview

• Status: Completed
• Conditions: Gynecological Surgery; Plastic Surgery; ENT Surgery
• Intervention / Treatment: Device: Insorb resorbable staples; Device: Monocryl resorbable wire

• Study Type: Interventional
• Enrollment (Actual): 664
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Amiens, France
    • Amiens University Hospital
  • Angers, France
    • Angers University Hospital
  • Besançon, France
    • Besançon University Hospital
  • Bordeaux, France
    • Bordeaux University Hospital "Centre FX. Michelet"
  • Brest, France
    • Brest University Hospital "Hôpital du Morvan"
  • Caen, France
    • Caen University Hospital "Hôpital de la Côte de Nacre"
  • Lille, France
    • Lille University Hospital "Hôpital Roger Salengro"
  • Marseille, France
    • "Assistance Publique des Hôpitaux de Marseille - La Conception"
  • Montpellier, France
    • Montpellier University Hospital "Hôpital Gui de Chauliac"
  • Mulhouse, France
    • Mulhouse Hospital "Emile Muller"
  • Nantes, France
    • CHU Nantes
  • Nice, France
    • "Institut de Cancérologie de Nice"
  • Paris, France
    • "Assistance Publique des Hôpitaux de Paris - Hôpital Bichat"
  • Poitiers, France
    • CHU Poitiers
  • Poitiers, France
    • Poitiers University Hospital
  • Rennes, France
    • Rennes University Hospital
  • Rennes, France
    • Rennes University Hospital "CHU Pontchaillou"
  • Rouen, France
    • Rouen University Hospital
  • Strasbourg, France
    • Strasbourg University Hospital "Hôpital Hautepierre"
  • Toulouse, France
    • "Institut Claudius Regaud"
  • Tours, France
    • Tours University Hospital
  • Tours, France
    • "Pôle Santé Léonard de Vinci"
  • Tours, France
    • Pôle Santé Léonard de Vinci
  • Pays de la Loire
    • Nantes, Pays de la Loire, France, 44000
      • CHU de Nantes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Resorbable staples; Suture using Insorb Resorbable staples	Device: Insorb resorbable staples; Subcutanous suture using resorbable staples; Other Names: Insorb staples
Active Comparator: Resorbable wires; Suture using Monocryl resorbable wire	Device: Monocryl resorbable wire; Subcutanous suture using resorbable wire; Other Names: Monocryl Wire

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incremental cost-effectiveness ratio (ICER) or average cost of suture according to the procedure (wire or staple)		Day 0 (Procedure)
Presence of scarring complications at day 8 (infection, dehiscence)		Day 8
Measurement of suture, surgical and anesthetic times		Day 0 (procedure)
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
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
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
Quantification of accidental exposure to blood		During the surgery

Collaborators and Investigators

• Sponsor: Nantes University Hospital
• Investigators: Principal Investigator: Olivier Malard, Professor, CHU Nantes

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: February 21, 2012
• First Submitted That Met QC Criteria: March 6, 2012
• First Posted (Estimate): March 7, 2012

Study Record Updates

• Last Update Posted (Estimate): March 8, 2016
• Last Update Submitted That Met QC Criteria: March 7, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: Medico-economic evaluation; Subcutaneous resorbable sutures; Tolerance / effectiveness of subcutaneous suture; Reduced operative time and anesthesia time; Accidental exposure to blood
• Other Study ID Numbers: RC11_0147