NCT01546272

Medico-economic Evaluation of Subcutaneous Automatic Resorbable Staples Device

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 664 (actual)
• Sponsor: Nantes University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• ENT Surgery
• Gynecological Surgery
• Plastic Surgery

Interventions

Type	Name	Description
DEVICE	Insorb resorbable staples	Subcutanous suture using resorbable staples
DEVICE	Monocryl resorbable wire	Subcutanous suture using resorbable wire

Timeline

• Start date: 2012-03-01
• Primary completion: 2014-05-01
• Completion: 2015-11-01
• First posted: 2012-03-07
• Last updated: 2016-03-08

Locations

24 sites across 1 country: France