NCT01218269

U-clip Pilot Study in Plastic Surgery

A Prospective Evaluation of U-clips for Arterial Microvascular Anastomoses

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Scott and White Hospital & Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study will assess the nitinol U-clip as an alternative to conventional microsurgical suture for arterial anastomoses in free tissue transfer.

Detailed description

Within Scott \& White, a total of 25 free flaps will be performed using U-clips for microvascular anastomoses in lieu of traditional suturing techniques. Each of these free flaps may be in individual patients or two anastomoses may be included in one patient. Historical controls will be used for comparison of complication rates of U-clip versus sutured anastomoses. Postoperatively, the study participants will be evaluated at 2 weeks (+/- 1 week) and at 3 months (+/- 1 month) follow up.

Conditions

• Microvascular Anastomoses

Interventions

Type	Name	Description
DEVICE	nitinol u-clip	The U-clip is comprised of nitinol, an alloy of nickel and titanium.

Timeline

• Start date: 2009-10-01
• Primary completion: 2010-10-01
• Completion: 2010-10-01
• First posted: 2010-10-11
• Last updated: 2011-03-01

Locations

1 site across 1 country: United States