A Clinical Trial Using Spy Elite System in Planning Tissue Advancement Flaps After Ventral Hernia Repair
| Status: | Completed |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | November 2011 |
| End Date: | April 2016 |
| Contact: | Amy Lincourt, PhD, MBA |
| Email: | Amy.Lincourt@carolinashealthcare.org |
| Phone: | 704-355-8787 |
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.
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.
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.
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.
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
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