Medico-economic Evaluation of Subcutaneous Automatic Resorbable Staples Device

Study Overview
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Brief Summary
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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.

Official Title
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Medico-economic Evaluation of Subcutaneous Automatic Resorbable Staples Device

Conditions
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ENT Surgery, Gynecological Surgery, Plastic Surgery

Intervention / Treatment
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* Device: Insorb resorbable staples
* Device: Monocryl resorbable wire


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Resorbable staples<br>Suture using Insorb Resorbable staples | Device: Insorb resorbable staples<br>* Subcutanous suture using resorbable staples<br>* Other names: Insorb staples;|
| Active Comparator: Resorbable wires<br>Suture using Monocryl resorbable wire | Device: Monocryl resorbable wire<br>* Subcutanous suture using resorbable wire<br>* Other names: Monocryl Wire;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Subcutaneous resorbable sutures, Tolerance / effectiveness of subcutaneous suture, Reduced operative time and anesthesia time, Medico-economic evaluation, Accidental exposure to blood