Microvascular Anastomoses
Conditions
Keywords
anastomoses
Brief summary
This study will assess the nitinol U-clip as an alternative to conventional microsurgical suture for arterial anastomoses in free tissue transfer.
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.
Interventions
DEVICEnitinol u-clip
The U-clip is comprised of nitinol, an alloy of nickel and titanium.
Sponsors
Scott and White Hospital & Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Flap failure rate compared to published rate for conventional suture anastomoses | will be measured 3 months postoperative (+/- 2 weeks) |
Secondary
| Measure | Time frame |
|---|---|
| Rapid, reproducible, sutureless microvascular arterial anastomoses in free flaps without compromising patient outcomes. | data collected at 3 months postoperative (+/- 2 weeks) |
Countries
United States
Outcome results
None listed