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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01546272
First received: February 21, 2012
Last updated: March 10, 2014
Last verified: March 2014
  Purpose

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 Intervention Phase
ENT Surgery
Gynecological Surgery
Plastic Surgery
Device: Insorb resorbable staples
Device: Monocryl resorbable wire
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Medico-economic Evaluation of Subcutaneous Automatic Resorbable Staples Device

Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • Overall PSAS score measured 3 months after the surgery [ Time Frame: 3 months after the surgery ] [ Designated as safety issue: No ]
    Overall PSAS score measured 3 months after the surgery(PSAS : "Patient Scar Assessment Scale")


Secondary Outcome Measures:
  • Incremental cost-effectiveness ratio (ICER) or average cost of suture according to the procedure (wire or staple) [ Time Frame: Day 0 (Procedure) ] [ Designated as safety issue: No ]
  • Presence of scarring complications at day 8 (infection, dehiscence) [ Time Frame: Day 8 ] [ Designated as safety issue: Yes ]
  • Measurement of suture, surgical and anesthetic times [ Time Frame: Day 0 (procedure) ] [ Designated as safety issue: No ]
  • Overall score of the PSAS scale [ Time Frame: Months 3, 12 and 18 ] [ Designated as safety issue: No ]
    The tolerance will be assessed by the overall score of the PSAS scale (Patient Scar Assessment Scale)

  • Overall score of the OSAS scale [ Time Frame: Months 3, 12 and 18 ] [ Designated as safety issue: No ]
    The scar quality will be assessed by the overall score of the OSAS scale (Observer Scar Assessment Scale)

  • Aesthetic quality of the scar [ Time Frame: Month 18 ] [ Designated as safety issue: No ]
    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

  • Quantification of accidental exposure to blood [ Time Frame: During the surgery ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 660
Study Start Date: March 2012
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01546272

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

No publications provided

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01546272     History of Changes
Other Study ID Numbers: RC11_0147
Study First Received: February 21, 2012
Last Updated: March 10, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

ClinicalTrials.gov processed this record on April 17, 2014