U-clip Pilot Study in Plastic Surgery

February 28, 2011 updated by: Scott and White Hospital & Clinic

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Temple, Texas, United States, 76508
        • Scott and White Hospital and Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: no arms
all patients will receive the treatment - there is only one arms
Device: nitinol u-clip
The U-clip is comprised of nitinol, an alloy of nickel and titanium.
Other Names:
  • Coalescent Surgical U-CLIPTbl

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Flap failure rate compared to published rate for conventional suture anastomoses
Time Frame: will be measured 3 months postoperative (+/- 2 weeks)
will be measured 3 months postoperative (+/- 2 weeks)

Secondary Outcome Measures

Outcome Measure
Time Frame
Rapid, reproducible, sutureless microvascular arterial anastomoses in free flaps without compromising patient outcomes.
Time Frame: data collected at 3 months postoperative (+/- 2 weeks)
data collected at 3 months postoperative (+/- 2 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Scott and White Hospital & Clinic

Investigators

  • Principal Investigator: Raman C Mahabir, MD, Scott & White

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

October 7, 2010

First Submitted That Met QC Criteria

October 8, 2010

First Posted (Estimate)

October 11, 2010

Study Record Updates

Last Update Posted (Estimate)

March 1, 2011

Last Update Submitted That Met QC Criteria

February 28, 2011

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SWHospital - 90415

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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