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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
664
Subcutanous suture using resorbable staples
Subcutanous suture using resorbable wire
CHU de Nantes
Nantes, Pays de la Loire Region, France
Amiens University Hospital
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
...and 14 more locations
Overall PSAS score measured 3 months after the surgery
Overall PSAS score measured 3 months after the surgery(PSAS : "Patient Scar Assessment Scale")
Time frame: 3 months after the surgery
Incremental cost-effectiveness ratio (ICER) or average cost of suture according to the procedure (wire or staple)
Time frame: Day 0 (Procedure)
Presence of scarring complications at day 8 (infection, dehiscence)
Time frame: Day 8
Measurement of suture, surgical and anesthetic times
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: Month 18
Quantification of accidental exposure to blood
Time frame: During the surgery
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