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

Ventral Hernia Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01886963
• Other study ID #: 101106A
• Status: Completed
• Phase: N/A
• Start date: November 2011
• Est. completion date: October 2015

Study information

• Verified date: November 2021
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Hernia, Ventral
• Ventral Hernia

Intervention

Device:
• SPY - Unblinded use of SPY Elite
Surgeon plans tissue advancement flaps with the aid of Spy Elite System imaging
• Control - Blinded use of SPY Elite
Surgeon is blinded to Spy Elite imaging and plans tissue advancement flaps according to clinical judgment alone

Locations

Country	Name	City	State
United States	Atrium Health - Carolinas Medical Center	Charlotte	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	Novadaq Technologies ULC, now a part of Stryker

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Wound Complications	breakdown, necrosis, erythema, infection, or dehiscence with location specified	12 Weeks