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.
|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|
- 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 ]
- 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 ]
|Study Start Date:||October 2009|
|Study Completion Date:||October 2010|
|Primary Completion Date:||October 2010 (Final data collection date for primary outcome measure)|
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
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.
|United States, Texas|
|Scott and White Hospital and Clinic|
|Temple, Texas, United States, 76508|
|Principal Investigator:||Raman C Mahabir, MD||Scott & White|