This is a single-blinded multi-institutional randomized controlled trial to evaluate the
effectiveness of Arista hemostatic matrix powder (Arista® AH, C. R. Bard, Inc. Davol,
Warwick, RI) in reducing drainage output in anterolateral thigh (ALT) free flap donor
sites. Increased drainage from donor sites can lead to seroma formation with possible
secondary infection, delayed hospital discharge, and additional home care needs for drain
care. Arista is an inert plant based absorbable surgical hemostatic powder that can be
easily applied to broad surgical fields to reduce bleeding and seroma rates. Therefore,
its application to free flap donor sites may bear significant potential benefit.

Specific Aim 1: The main hypothesis of the study is that the use of Arista in
anterolateral thigh (ALT) free flap donor sites prior to closure will reduce
postoperative drain outputs and time to drain removal compared to ALT donor sites closed
without Arista.

Specific Aim 2: This study will also evaluate the secondary hypotheses that Arista will
reduce postoperative ALT donor site seromas and patient hospital length of stay.

Arista for ALT Donor Sites to Reduce Drain Output

Seroma

Free tissue transfer is a commonly performed procedure, especially at tertiary care
hospitals. In free tissue transfer, "spare tissue" from one area of the body (donor site)
is re-implanted to an area that is need of reconstruction (defect site). When relocated,
the "spare tissue" is given vitality and blood supply at its new location by
microscopically sewing and connecting its feeding artery and vein to an artery and vein
in or near the defect site. Hence, this operation is referred to as "microvascular free
tissue transfer" or "free flap". Defect sites most commonly result from tumor or cancer
removal and trauma related injuries. Free flaps are frequently used to reconstruct breast
tissue after mastectomy, head and neck cancer resections, extremity injuries, and
chronically infected wounds. The indications, utilization, and expertise in free flap
surgery continue to grow, providing patients with enhanced outcomes of otherwise
difficult cancers and wounds.

Since its original description in 1984 the ALT microvascular free flap has become an
increasingly integral part of head and neck reconstructive surgery.1, 2 ALT free flaps
have been shown to be a reliable method for several reconstructive procedures with
minimal donor site morbidity.2-4 The ALT free flap is composed of skin, subcutaneous
tissue, and fat of the anterolateral thigh. The blood supply to this area is from the
lateral circumflex femoral artery and vein. These vessels along with the tissues of the
anterolateral thigh are carefully dissected and removed as a single unit to be
re-implanted in a different part of the body.

Multiple options exist for soft tissue free flap donor sites similar to the ALT. However,
a distinct advantage of the ALT free flap over others is the minimal donor site morbidity
that the patient undergoes. Patients are able to fully ambulate and function after the
surgery, and are left with only a well-healed scar line. Despite its many advantages,
postoperative fluid collections continue to be problematic in the ALT donor site. Studies
have reported seroma rates in ALT donor sites as high as 5% although this likely
underestimates the true incidence of clinically significant postoperative fluid
collections and wound complications in this patient population.2 ALT free flaps require a
large amount of tissue dissection and removal, creating a large potential space in the
lateral thigh that often requires prolonged postoperative suction drainage and pressure
dressings in efforts to minimize fluid accumulation.

Research in optimal postoperative management for the ALT donor site is lacking. Current
management without the use of Arista often requires a surgical drain for 7-14 days, which
can delay patient discharge and expose patients to increased risk of postoperative wound
infections. There is a paucity of data on methods to reduce ALT donor site drain output
and seromas. Surgeons often use a combination of closed suction surgical drains and
pressure dressings to try and reduce the amount of fluid collection in the thigh donor
sites. Although this does provide some advantage, if these techniques are required for a
prolonged time, unnecessary hospital stay and patient morbidity are attained. According
the Healthcare Cost and Utilization Project, an average inpatient hospitalization in 2009
cost $2,000 per day, and is increasing.5 If the use of a single bottle of Arista could
reduce just 1 hospital day per patient it could save at least $80,000 dollars a year at
our department alone. Further, the associated morbidity and health care costs of
potential seroma or infected seroma complications may be avoided.

A randomized controlled trial aimed at evaluating improved methods to reduce
postoperative drainage from ALT donor sites could provide critical information on how to
best serve our patients, eliminate unnecessary hospital stay, and reduce overall cost.
Once studied in a controlled single flap environment, these methods could be then
expanded to other or all free flap donor sites.

According to the manufacturer, Arista uses Microporous Polysaccharide Hemospheres (MPH)
technology to catalyze the clotting cascade and effectively dehydrate tissue to initiate
hemostasis in broad areas. Major advantages of Arista are that it has been shown to be
safe and effective across multiple surgical disciplines, is completely absorbed in 24-48
hours, and contains no human or animal components.6-8

Sindwani et al. was the first to report effectiveness and safety of Arista as a
hemostatic agent in otolaryngology demonstrating its application in controlling
postoperative bleeding after endoscopic sinus surgery.8 Zhang et al. demonstrated success
rate of 100% in the prevention of seromas in patients undergoing resection of malignant
tumors in multiple locations, including the lower extremity.7 Arista was recently shown
to be useful in reducing postoperative chest tube output and hemostasis time in patients
undergoing cardiothoracic surgery.6

These previous works support the idea that Arista could be effective in reducing
postoperative fluid collection and drainage time in free flap donor sites. However, this
would be a new application of Arista with wide applicability that has not been previously
described.

1.1 Research Rationale and Possible Influence On Clinical Practice

Reconstructive surgery has evolved in a recent era of increased attention to patient
satisfaction and cost savings. The ALT free flap has been proven to be highly successful;
however, optimal management of the donor site postoperatively is an area in need of
additional gains via research. Decreasing free flap donor site drain output and earlier
drain removal could improve the quality of life of our patients, significantly decrease
the cost of their care, and potentially decrease drain-associated infections. If this
study were to demonstrate Arista to reduce postoperative donor site drainage and seroma
rates and/or a decrease in hospital length of stay resulting from early surgical drain
removal, it could dramatically affect the way we take care of our patients.

This study seeks to critically evaluate current clinical practice paradigms to better
understand the influence of Arista use in free flap donor sites. A prospective,
multi-institutional, randomized, controlled, single-blinded trial is the clearest
methodology to evaluate the possible benefits of Arista. Additionally, study in the ALT
free flap alone, a single and commonly performed free flap, limits bias and confounding
variables. No clinical trial of this level has been performed on this topic; thus, our
proposal is novel and the findings of the study are potentially important.

ARISTA

Multi-Institutional Randomized Controlled Trial Evaluating Use of Arista Absorbable Surgical Hemostatic Powder in Anterolateral Thigh Donor Sites

The primary outcome analyzed in this study will be total drain output (mL) in an effort
to determine if the addition of Arista to the wound bed decreases overall wound drainage
and drain output.

ALT donor site will be evaluated for seroma

Given that drain output influences time of drain removal, assessment will be made to
determine if timing of drain removal differs between groups.

Will eval hospital length of stay for both groups

Arista for ALT Donor Sites to Reduce Drain Output

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Trial Timing

What is this trial about?

What are the participation requirements?

Locations

Location

Status