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N/A N=115 Randomized Double-blind Treatment

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

Ventral Hernia

Enrolled (actual)
115
Serious AEs
7.4%
Results posted
Jun 2016
Primary outcome: Primary: Number of Participants With Wound Complications — 16; 17 participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
SPY - Unblinded use of SPY Elite (Device); Control - Blinded use of SPY Elite (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Wake Forest University Health Sciences
Primary completion
Oct 2015

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants With Wound Complications
16; 17

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.

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01886963). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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