U-clip Pilot Study in Plastic Surgery

This study has been completed.
Sponsor:
Information provided by:
Scott and White Hospital & Clinic
ClinicalTrials.gov Identifier:
NCT01218269
First received: October 7, 2010
Last updated: February 28, 2011
Last verified: September 2010
  Purpose

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


Condition Intervention Phase
Microvascular Anastomoses
Device: nitinol u-clip
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Evaluation of U-clips for Arterial Microvascular Anastomoses

Further study details as provided by Scott and White Hospital & Clinic:

Primary Outcome Measures:
  • Flap failure rate compared to published rate for conventional suture anastomoses [ Time Frame: will be measured 3 months postoperative (+/- 2 weeks) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Rapid, reproducible, sutureless microvascular arterial anastomoses in free flaps without compromising patient outcomes. [ Time Frame: data collected at 3 months postoperative (+/- 2 weeks) ] [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: October 2009
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Coalescent Surgical U-CLIPTbl

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01218269

Locations
United States, Texas
Scott and White Hospital and Clinic
Temple, Texas, United States, 76508
Sponsors and Collaborators
Scott and White Hospital & Clinic
Investigators
Principal Investigator: Raman C Mahabir, MD Scott & White
  More Information

No publications provided

Responsible Party: Raman Chaos Mahabir, MD, MSc, FRCSC, Scott and White
ClinicalTrials.gov Identifier: NCT01218269     History of Changes
Other Study ID Numbers: SWHospital - 90415
Study First Received: October 7, 2010
Last Updated: February 28, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Scott and White Hospital & Clinic:
anastomoses

ClinicalTrials.gov processed this record on July 31, 2014