Status:

COMPLETED

A Clinical Trial Using Spy Elite System in Planning Tissue Advancement Flaps After Ventral Hernia Repair

Lead Sponsor:

Wake Forest University Health Sciences

Collaborating Sponsors:

Novadaq Technologies ULC, now a part of Stryker

Conditions:

Ventral Hernia

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

The purpose of this project is to assess the efficacy of the Spy Elite System (LifeCell Corporation, Branchburg, NJ, USA) in planning tissue advancement flaps and reducing wound complications after co...

Detailed Description

More than 90,000 ventral hernia repairs are performed in the US annually. Large ventral hernias often require a complex abdominal wall reconstruction including creating tissue advancement flaps. Compl...

Eligibility Criteria

Inclusion

  • Patients with ventral hernia that will require tissue advancement flaps at time of hernia repair
  • Age ≥ 18 years
  • Signed informed consent

Exclusion

  • ASA score IV or above
  • Age \< 18 years
  • Patients with iodine allergy
  • Patients with current wound or mesh infection
  • Pregnant patients
  • Patients with End Stage Renal Disease

Key Trial Info

Start Date :

November 1 2011

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

October 1 2015

Estimated Enrollment :

115 Patients enrolled

Trial Details

Trial ID

NCT01886963

Start Date

November 1 2011

End Date

October 1 2015

Last Update

April 21 2022

Active Locations (1)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (1 locations)

1

Atrium Health - Carolinas Medical Center

Charlotte, North Carolina, United States, 28203