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NCT Number: NCT01886963

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

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 complex ventral hernia repairs. Complex ventral hernia repairs are associated with a high rate of wound complications. To a large degree these complications are caused by creating tissue advancement flaps to close the abdomen, which can compromise the blood supply to the skin and subcutaneous tissues. The current standard of care for assessment of blood perfusion to the flaps is a surgeon's clinical judgment. It is, however, often inaccurate. The Spy Elite System was developed to address this problem. The Spy Elite System is a device that enables surgeons to visualize and evaluate tissue perfusion in real time. It can help the surgeon to identify optimal flap design and reduce the risk of postoperative wound complications related to tissue ischemia. The primary goal of this study is to evaluate the efficacy of Spy Elite System to aid a surgeon in creating tissue flaps with adequate blood supply through a prospective, randomized clinical trial. The Spy Elite System has been used successfully for assessing the viability of mastectomy flaps in breast surgery and has been shown to be extremely sensitive in predicting mastectomy flap necrosis. However, no clinical trial has been conducted in order to evaluate the efficacy of the Spy Elite System for assessing the viability of abdominal subcutaneous flaps in complex ventral hernia repairs.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Atrium Health - Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

About this study

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. Complex abdominal wall reconstructions are associated with up to 20% rate of wound complications including skin flap necrosis and wound breakdowns. Prevention of skin necrosis and ischemia would significantly reduce the morbidity associated with these procedures.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

SPY - Unblinded use of SPY Elite

Device

Surgeon plans tissue advancement flaps with the aid of Spy Elite System imaging

Control - Blinded use of SPY Elite

Device

Surgeon is blinded to Spy Elite imaging and plans tissue advancement flaps according to clinical judgment alone

Primary outcomes

  1. Number of Participants With Wound Complications

    Time frame: 12 Weeks

    breakdown, necrosis, erythema, infection, or dehiscence with location specified

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • Novadaq Technologies ULC, now a part of Stryker

Registry information

Official study title

A Randomized, Prospective, Double-Blind Clinical Trial Using Spy Elite System in Planning Tissue Advancement Flaps and Reducing Wound Complications After Complex Ventral Hernia Repairs

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Jun 26, 2013
Registry last updated
Apr 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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