U-clip Pilot Study in Plastic Surgery

A Prospective Evaluation of U-clips for Arterial Microvascular Anastomoses

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

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.

Inclusion Criteria:

• either gender
• any ethnicity
• patient requiring free tissue transfer for complex wound coverage or reconstruction
• patient having arterial anastomotic diameter of at least 2 mm
• patient capable of giving informed consent

Exclusion Criteria:

• less than 18 years of age
• allergy to nitinol or any of its components (nickel or titanium)
• pregnancy
• known coagulopathy