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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01546272
Recruitment Status : Completed
First Posted : March 7, 2012
Last Update Posted : March 8, 2016
Information provided by (Responsible Party):
Nantes University Hospital

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.

Condition or disease Intervention/treatment Phase
ENT Surgery Gynecological Surgery Plastic Surgery Device: Insorb resorbable staples Device: Monocryl resorbable wire Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 664 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Medico-economic Evaluation of Subcutaneous Automatic Resorbable Staples Device
Study Start Date : March 2012
Actual Primary Completion Date : May 2014
Actual Study Completion Date : November 2015

Arm Intervention/treatment
Experimental: Resorbable staples
Suture using Insorb Resorbable staples
Device: Insorb resorbable staples
Subcutanous suture using resorbable staples
Other Name: Insorb staples

Active Comparator: Resorbable wires
Suture using Monocryl resorbable wire
Device: Monocryl resorbable wire
Subcutanous suture using resorbable wire
Other Name: Monocryl Wire

Primary Outcome Measures :
  1. Overall PSAS score measured 3 months after the surgery [ Time Frame: 3 months after the surgery ]
    Overall PSAS score measured 3 months after the surgery(PSAS : "Patient Scar Assessment Scale")

Secondary Outcome Measures :
  1. Incremental cost-effectiveness ratio (ICER) or average cost of suture according to the procedure (wire or staple) [ Time Frame: Day 0 (Procedure) ]
  2. Presence of scarring complications at day 8 (infection, dehiscence) [ Time Frame: Day 8 ]
  3. Measurement of suture, surgical and anesthetic times [ Time Frame: Day 0 (procedure) ]
  4. Overall score of the PSAS scale [ Time Frame: Months 3, 12 and 18 ]
    The tolerance will be assessed by the overall score of the PSAS scale (Patient Scar Assessment Scale)

  5. Overall score of the OSAS scale [ Time Frame: Months 3, 12 and 18 ]
    The scar quality will be assessed by the overall score of the OSAS scale (Observer Scar Assessment Scale)

  6. Aesthetic quality of the scar [ Time Frame: Month 18 ]
    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

  7. Quantification of accidental exposure to blood [ Time Frame: During the surgery ]

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01546272

CHU de Nantes
Nantes, Pays de la Loire, France, 44000
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
Sponsors and Collaborators
Nantes University Hospital
Principal Investigator: Olivier Malard, Professor CHU Nantes

Responsible Party: Nantes University Hospital Identifier: NCT01546272     History of Changes
Other Study ID Numbers: RC11_0147
First Posted: March 7, 2012    Key Record Dates
Last Update Posted: March 8, 2016
Last Verified: March 2016

Keywords provided by Nantes University Hospital:
Subcutaneous resorbable sutures
Tolerance / effectiveness of subcutaneous suture
Reduced operative time and anesthesia time
Medico-economic evaluation
Accidental exposure to blood