U-clip Pilot Study in Plastic Surgery
This study has been completed.
Sponsor:
Scott and White Hospital & Clinic
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
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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
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 May 19, 2013