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

NCT ID: NCT01886963

Last Updated: 2022-04-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 115 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2015-10-31

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 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.

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.

Conditions

Ventral Hernia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

SPY - Unblinded use of SPY Elite

Intervention Type: DEVICE

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

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.

Group Type: ACTIVE_COMPARATOR

Control - Blinded use of SPY Elite

Intervention Type: DEVICE

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

Interventions

SPY - Unblinded use of SPY Elite

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

Intervention Type: DEVICE

Control - Blinded use of SPY Elite

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novadaq Technologies ULC, now a part of Stryker

INDUSTRY

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brant T Heniford, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Atrium Health - Carolinas Medical Center

Charlotte, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

101106A

Identifier Type: -

Identifier Source: org_study_id