Medico-economic Evaluation of Subcutaneous Automatic Resorbable Staples Device — S2CARA  

Gynecological Surgery Clinical Trial

Official title: Medico-economic Evaluation of Subcutaneous Automatic Resorbable Staples Device

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• ENT Surgery
• Gynecological Surgery
• Plastic Surgery

• NCT number: NCT01546272
• Study type: Interventional
• Source: Nantes University Hospital
• Status: Completed
• Phase: Phase 3
• Start date: March 2012
• Completion date: November 2015