Floraseal Versus Iodine Impregnated Adhesive Drapes

Demand for Total Knee Arthroplasty (TKA) and Total Hip Arthroplasty (THA) is increasing
steadily and is projected to continue trending upwards in the coming years. Postoperative
infections are a common but also potentially devastating complication of total joint
arthroplasty.

Various strategies are employed both pre-operatively and post-operatively to prevent this
complication. A 2011 Cochrane Review concluded that Iodine impregnated adhesive drapes had no
impact on surgical site infection rate when used in various surgical procedures not specific
to orthopaedics. The recent SSI prevention guidelines by the World Health Organization did
not find any evidence to support the use of adhesive drapes during surgery and recommends
against its use.

Currently, iodine impregnated adhesive drapes in conjunction with either chorahexadine
gluconate or Iodine Povacrylex and Isopropyl Alcohol are the standard of care at our
institution.

FloraSeal is a cyanoacrylate-based sealant. A cyanoacrylate microbial sealant minimizes
endogenous bacteria spread to the surgical site by forming a sterile film bonded onto a
patient's skin. This film, which is formed upon polymerization, prevents the spread of
microorganisms. The protective mechanism is mechanical: the film traps and immobilizes
microorganisms that survive on a patient's skin. It has been previously shown to effectively
immobilize both gram positive and gram negative bacteria. Additionally, the sealant itself
can effectively reduce the superficial bacterial burden on the skin surface and also helps
reduce skin moisture buildup on skin.

Furthermore, with conventional adhesive drapes, the edges must be peeled back at the time of
skin closure in order to effectively close the surgical site. It is at this moment that the
incision becomes most vulnerable to penetration by local microorganisms. FloraSeal and other
cyanoacrylate based sealants remain on the skin for 5 to 10 days until the superficial skin
sloughs off.

Studies on sterile pig skin demonstrated FloraSeal to be more effective alone at immobilizing
bacteria than incisional drapes. The efficacy was the same when FloraSeal was used with or
without the incisional drapes, demonstrating that it may be used as a substitute.

Additionally, a 2013 retrospective study in revision shoulder arthroplasty demonstrated a
potential reduction in positive intraoperative deep tissue cultures when using a
cyanoacrylate-based microbial sealant versus the iodine impregnated incisional drapes. The
study lacked sufficient power to reach significance, calling for further investigation of
this effect.

Cyanoacrylate has been investigated in other surgical interventions. A 2008 prospective,
randomized multicenter clinical trial in patients undergoing elective open hernia repair
demonstrated cyanoacrylate-based microbial sealant independently reduced wound contamination
over the course of the operation.

Due to the potentially devastating complications associated with postoperative infection, the
investigators seek to find alternative methods of prevention of surgical site infection.

Inclusion Criteria:

- > 18 years of age

- Have signed the written informed consent form

Exclusion Criteria:

- Patients not fluent in the language of the informed consent form

- Prisoners

- Pregnancy

- Reported to have mental illness or belonging to a vulnerable population

- History of dermatitis or allergic reaction to cyanoacrylate based materials or iodine

- Patients undergoing revision total joint arthroplasty secondary to infection

- Allergy to Iodine.

- Patients undergoing total joint arthroplasty in the setting of acute trauma