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

Nantes University Hospital (NUH)

Status and phase

Completed

Phase 3

Conditions

Gynecological Surgery

ENT Surgery

Plastic Surgery

Treatments

Device: Monocryl resorbable wire

Device: Insorb resorbable staples

Study type

Interventional

Funder types

Other

Identifiers

NCT01546272

RC11_0147

Details and patient eligibility

About

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.

Enrollment

664 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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