This is a prospective, one site, randomized controlled trial. The goal of this project is
to evaluate the efficacy of subdermal 10% povidone-iodine at reducing bacterial
contamination from the subdermal layer of skin during posterior spinal fusion. The
primary outcome of this study will be incidence of positive bacterial growth in several
layers of the surgical wound. Secondary outcomes will be complications, including
allergic reactions, contact dermatitis, surgical site infection and wound complications.
Finally, patient and surgical variables that can effect microbial growth will be
observed.
Once identified, the surgeon and coordinators will discuss risks, benefits, advantages,
and disadvantages of this study to eligible patients. If the family wishes to enroll, the
patient's family and patient will be consented. And automatically randomized to either
povidone-iodine vs control group (predetermined according to the statistician). All
patients will follow the standardized spine pathway including standard antibiotics and
skin preparation with isopropyl alcohol followed by ChloraPrepTM and sterile draping.
Five bacterial cultures will be obtained throughout the spinal fusion similarly for all
patients by rubbing along the entirety of the posterior spinal incision. The first two
cultures will be taken before the placement of an antimicrobial adhesive drape and after
the initial incision in the subdermal layer. The surgeon will be notified which group the
patients are in. Patients who were randomized to the povidone-iodine group will then have
three topical applications of 10% povidone-iodine along the length of the subdermis,
using each of the 3 swab sticks provided from the sterile single-use packet. Patients who
were randomized to the control group will then have three applications of sterile saline
along the length of the subdermis, using each of the 3 swab sticks soaked in sterile
saline. Following the 10% povidone-iodine or saline application, the solution will be
allowed to dry at least three minutes and a third culture will be obtained. Surgical
exposure will proceed in all patients, and an additional culture will be obtained along
the length of the deep wound after exposure, and a final culture along the length of the
deep wound just prior to wound closure. The swabs will be cultured, and the final results
will be reported however, the surgeons delivering patient care will be blinded to the
results to mitigate competing interests. Routine postoperative care will follow standard
of care no matter the culture results. A data safety monitor will assure no correlation
between culture results and infection rate.
