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

March 7, 2016 updated by: Nantes University Hospital
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
664

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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
        • Pole Sante Leonard de Vinci
    • Pays de la Loire
      • Nantes, Pays de la Loire, France, 44000
        • CHU de Nantes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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")
3 months after the surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incremental cost-effectiveness ratio (ICER) or average cost of suture according to the procedure (wire or staple)
Time Frame: Day 0 (Procedure)
Day 0 (Procedure)
Presence of scarring complications at day 8 (infection, dehiscence)
Time Frame: Day 8
Day 8
Measurement of suture, surgical and anesthetic times
Time Frame: Day 0 (procedure)
Day 0 (procedure)
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)
Months 3, 12 and 18
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)
Months 3, 12 and 18
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
Month 18
Quantification of accidental exposure to blood
Time Frame: During the surgery
During the surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nantes University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Olivier Malard, Professor, CHU Nantes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 21, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 7, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 8, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 7, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RC11_0147

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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