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

NCT01886963 | Completed Results DMC FDA Device

• 1 other identifier: 101106A
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventral Hernia

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Wound Complications

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

  12 Weeks

Study Arms (2)

Control - Blinded use of SPY Elite

ACTIVE COMPARATOR

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

SPY - Unblinded Use of SPY Elite

EXPERIMENTAL

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

Interventions

SPY - Unblinded use of SPY Elite DEVICE

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

SPY - Unblinded Use of SPY Elite

Control - Blinded use of SPY Elite DEVICE

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

Control - Blinded use of SPY Elite

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Atrium Health - Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

Location

MeSH Terms

Conditions

Hernia, Ventral

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Todd Heniford
• Organization: Carolinas HealthCare System

todd.heniford@carolinashealthcare.org

7043551813

Study Officials

• Brant T Heniford, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2013
• First Posted: June 26, 2013
• Study Start: November 1, 2011
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: April 21, 2022
• Results First Posted: June 28, 2016

Record last verified: 2021-11

Locations

US (1)