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OpenTrials
Completed

NCT Number: NCT01218269

U-clip Pilot Study in Plastic Surgery

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

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Key information

Conditions

Microvascular Anastomoses

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Scott and White Hospital and Clinic

Temple, Texas, 76508, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

nitinol u-clip

Device

The U-clip is comprised of nitinol, an alloy of nickel and titanium.

Other names: Coalescent Surgical U-CLIPTbl

Primary outcomes

  1. Flap failure rate compared to published rate for conventional suture anastomoses

    Time frame: will be measured 3 months postoperative (+/- 2 weeks)

Secondary outcomes

  1. Rapid, reproducible, sutureless microvascular arterial anastomoses in free flaps without compromising patient outcomes.

    Time frame: data collected at 3 months postoperative (+/- 2 weeks)

Sponsors and collaborators

Lead sponsor

Scott and White Hospital & Clinic

Other

Registry information

Official study title

A Prospective Evaluation of U-clips for Arterial Microvascular Anastomoses

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Oct 11, 2010
Registry last updated
Mar 1, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.