U-clip Pilot Study in Plastic Surgery

Scott and White Hospital & Clinic

Status and phase: Completed; Phase 4

Conditions: Microvascular Anastomoses

Treatments: Device: nitinol u-clip

Study type: Interventional

Funder types: Other

Identifiers

NCT01218269

SWHospital - 90415

Details and patient eligibility

About

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

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

no arms

Other group

Description:

all patients will receive the treatment - there is only one arms

Treatment:

Device: nitinol u-clip