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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Resorbable staples | Experimental | Suture using Insorb Resorbable staples |
|
| Resorbable wires | Active Comparator | Suture using Monocryl resorbable wire |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insorb resorbable staples | Device | Subcutanous suture using resorbable staples |
|
| 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 |
| 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 |
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Inclusion Criteria:
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
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Olivier Malard, Professor | Nantes University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Nantes | Nantes | Pays de la Loire Region | 44000 | France | ||
| Amiens University Hospital |
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| Monocryl resorbable wire | Device | Subcutanous suture using resorbable wire |
|
|
| 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 |
| 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 |