Status:

COMPLETED

U-clip Pilot Study in Plastic Surgery

Lead Sponsor:

Scott and White Hospital & Clinic

Conditions:

Microvascular Anastomoses

Eligibility:

All Genders

18+ years

Phase:

PHASE4

Brief 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 ...

Eligibility Criteria

Inclusion

  • 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

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

Key Trial Info

Start Date :

October 1 2009

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

October 1 2010

Estimated Enrollment :

25 Patients enrolled

Trial Details

Trial ID

NCT01218269

Start Date

October 1 2009

End Date

October 1 2010

Last Update

March 1 2011

Active Locations (1)

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1

Scott and White Hospital and Clinic

Temple, Texas, United States, 76508