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

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

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.

Study Overview

• Status: Completed
• Conditions: Ventral Hernia
• Intervention / Treatment: Device: Control - Blinded use of SPY Elite; Device: SPY - Unblinded use of SPY Elite

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. 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.

• Study Type: Interventional
• Enrollment (Actual): 115
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Charlotte, North Carolina, United States, 28203
      • Atrium Health - Carolinas Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control - Blinded use of SPY Elite; Group A will consist of intraoperative abdominal wall imaging prior to incision, followed by ventral hernia repair with subcutaneous advancement flaps without viewing the imaging contained within the Spy Elite system. A digital photograph will be taken before and immediately after initial incision, as well as immediately prior to and after closure. The patient will have digital photographs of the surgical wound taken by the surgical team daily until discharge, and on follow-up visits at one week, two weeks, four weeks and twelve weeks. After twenty patients have completed phase I, the surgical team will be unblinded to Spy Elite imaging. The Spy Elite imaging and all digital photographs of all patients will be reviewed.	Device: Control - Blinded use of SPY Elite; Surgeon is blinded to Spy Elite imaging and plans tissue advancement flaps according to clinical judgment alone
Experimental: SPY - Unblinded Use of SPY Elite; Group B will have incision and advancement flap performed based on assessment of blood supply using the Spy Elite system, as well as potential flap revision if portions of the flap appear under-perfused in the pre-closure imaging. Patients will be blinded to whether or not their intraoperative Spy Elite imaging was used for operative planning. All patients will have digital photographs of the surgical wound taken by a blinded member of the surgical team daily until discharge, and on follow-up visits at one to two weeks, four weeks, and 12 weeks post-operatively. Digital photographs will be reviewed by a blinded surgeon, who will assess the wound for complications.	Device: SPY - Unblinded use of SPY Elite; Surgeon plans tissue advancement flaps with the aid of Spy Elite System imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Wound Complications	breakdown, necrosis, erythema, infection, or dehiscence with location specified	12 Weeks

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: Novadaq Technologies ULC, now a part of Stryker

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: June 24, 2013
• First Submitted That Met QC Criteria: June 24, 2013
• First Posted (Estimate): June 26, 2013

Study Record Updates

• Last Update Posted (Actual): April 21, 2022
• Last Update Submitted That Met QC Criteria: April 19, 2022
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Ventral
• Other Study ID Numbers: 101106A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes