Ventral Hernia
Conditions
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.
Interventions
DEVICESPY - Unblinded use of SPY Elite
Surgeon plans tissue advancement flaps with the aid of Spy Elite System imaging
DEVICEControl - Blinded use of SPY Elite
Surgeon is blinded to Spy Elite imaging and plans tissue advancement flaps according to clinical judgment alone
Sponsors
Novadaq Technologies ULC, now a part of Stryker
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Wound Complications | 12 Weeks | breakdown, necrosis, erythema, infection, or dehiscence with location specified |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
Ventral Hernia Repair with Advancement Flaps with Blinded Use of Spy Elite (Control): Surgeon is blinded to Spy Elite imaging and plans tissue advancement flaps according to clinical judgment alone | 49 |
| 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 if intraoperative Spy Elite imaging was used. Digital photographs of the surgical wound taken by surgical team daily until discharge, and on follow-up visits post-operatively. Digital photographs will be reviewed by a blinded surgeon, who will assess the wound for complications (breakdown, necrosis, erythema, infection, or dehiscence with location specified) and assessment of healing. Upon study completion, groups will be compared for wound complications, presence of flap necrosis, quantification of flap necrosis, and healing speed.
VHR with Advancement Flaps with Unblinded Use of Spy Elite (Experimental): Surgeon plans tissue advancement flaps with the aid of Spy Elite System imaging | 46 |
| Total | 95 |
Baseline characteristics
| Characteristic | Total | Control - Blinded Use of SPY Elite | SPY - Unblinded Use of SPY Elite |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 22 Participants | 12 Participants | 10 Participants |
| Age, Categorical Between 18 and 65 years | 73 Participants | 37 Participants | 36 Participants |
| Age, Continuous | 57.6 years STANDARD_DEVIATION 11.43 | 58.3 years STANDARD_DEVIATION 11.76 | 56.7 years STANDARD_DEVIATION 11.16 |
| Region of Enrollment United States | 95 participants | 49 participants | 46 participants |
| Sex: Female, Male Female | 63 Participants | 32 Participants | 31 Participants |
| Sex: Female, Male Male | 32 Participants | 17 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 46 | 0 / 49 |
| serious Total, serious adverse events | 5 / 46 | 2 / 49 |
Outcome results
Primary
Number of Participants With Wound Complications
breakdown, necrosis, erythema, infection, or dehiscence with location specified
Time frame: 12 Weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group A | Number of Participants With Wound Complications | 16 participants |
| Group B | Number of Participants With Wound Complications | 17 participants |