S2CARA: Medico-economic Evaluation of Subcutaneous Automatic Resorbable Staples Device
Study Details
Study Description
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 |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Resorbable staples Suture using Insorb Resorbable staples |
Device: Insorb resorbable staples
Subcutanous suture using resorbable staples
Other Names:
|
| Active Comparator: Resorbable wires Suture using Monocryl resorbable wire |
Device: Monocryl resorbable wire
Subcutanous suture using resorbable wire
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Overall PSAS score measured 3 months after the surgery [3 months after the surgery]
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) [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 [Months 3, 12 and 18]
The tolerance will be assessed by the overall score of the PSAS scale (Patient Scar Assessment Scale)
- Overall score of the OSAS scale [Months 3, 12 and 18]
The scar quality will be assessed by the overall score of the OSAS scale (Observer Scar Assessment Scale)
- Aesthetic quality of the scar [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
- Quantification of accidental exposure to blood [During the surgery]
Eligibility Criteria
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CHU de Nantes | Nantes | Pays de la Loire | France | 44000 |
| 2 | Amiens University Hospital | Amiens | France | ||
| 3 | Angers University Hospital | Angers | France | ||
| 4 | Besançon University Hospital | Besançon | France | ||
| 5 | Bordeaux University Hospital "Centre FX. Michelet" | Bordeaux | France | ||
| 6 | Brest University Hospital "Hôpital du Morvan" | Brest | France | ||
| 7 | Caen University Hospital "Hôpital de la Côte de Nacre" | Caen | France | ||
| 8 | Lille University Hospital "Hôpital Roger Salengro" | Lille | France | ||
| 9 | "Assistance Publique des Hôpitaux de Marseille - La Conception" | Marseille | France | ||
| 10 | Montpellier University Hospital "Hôpital Gui de Chauliac" | Montpellier | France | ||
| 11 | Mulhouse Hospital "Emile Muller" | Mulhouse | France | ||
| 12 | CHU Nantes | Nantes | France | ||
| 13 | "Institut de Cancérologie de Nice" | Nice | France | ||
| 14 | "Assistance Publique des Hôpitaux de Paris - Hôpital Bichat" | Paris | France | ||
| 15 | CHU Poitiers | Poitiers | France | ||
| 16 | Poitiers University Hospital | Poitiers | France | ||
| 17 | Rennes University Hospital "CHU Pontchaillou" | Rennes | France | ||
| 18 | Rennes University Hospital | Rennes | France | ||
| 19 | Rouen University Hospital | Rouen | France | ||
| 20 | Strasbourg University Hospital "Hôpital Hautepierre" | Strasbourg | France | ||
| 21 | "Institut Claudius Regaud" | Toulouse | France | ||
| 22 | "Pôle Santé Léonard de Vinci" | Tours | France | ||
| 23 | Pôle Santé Léonard de Vinci | Tours | France | ||
| 24 | Tours University Hospital | Tours | France |
Sponsors and Collaborators
- Nantes University Hospital
Investigators
- Principal Investigator: Olivier Malard, Professor, CHU Nantes
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RC11_0147