General Session: Tumor, Trauma, and Infection

Presented by: T. Spencer - View Audio/Video Presentation (Members Only)


T. Spencer(1), B. Gorinshetyn(2), T. Ganey(3)

(1) Greater Michigan Spine and Neurological Institute, Battle Creek, MI, United States
(2) Nuvision Pharmaceuticals, Roswell, GA, United States
(3) Atlanta Medical Center, Orthopaedic Surgery, Atlanta, GA, United States


Introduction: The skin is a natural barrier against infection, and despite this continuous and impermeable protection, if skin is injured by blister, splinter, cut or burn, bacteria can enter the body and cause an infection. Breaks in the skin that occur during a surgical procedure present opportunities for pathogens to enter the body. BerbereX® Wound Cleanser has been cleared by FDA for external use. In vitro potency has been shown against high levels of several resistant bacteria, including against MRSA, B-strep, VRE, and E. col.i Based on the product's performance, a study was undertaken to evaluate 180 consecutive patients following spinal surgery.

Methods: Following IRB review, patients were evaluated from a single physician. No subjects were excluded from the study based on recognized associated risk factor(s). Patients were randomized to receive BerbereX® Wound Cleanser (NuVision Pharmaceuticals, Atlanta, GA) post-operatively at a 1:2 proportion, and asked to apply the solution twice a day for 6 months or until wound healing had occurred. Remaining patients evaluated in this retrospective analysis were asked to follow post-operative discharge instructions common to the practice that placed limitations on lifting, and that asked the patients to wash the incision wound with soap and water. The study evaluated efficacy in terms of preventing infections, and surgical site healing with regard to pain at the site of incision, tissue cosmesis, and patient compliance.

Results: 66 patients were treated with the BerbereX® Wound Cleanser; and 114 patients received the standard of care. Within the treated group there were128 surgical levels treated, whereas 198 surgical levels were treated by the standard of care; 1.93 levels per surgical procedure for the BerbereX®-treated and 1.73 levels for the standard-of-care patients. Over the course of the evaluation, assuring that all infections has been treated successfully - 11 patients who followed standard-of-care protocol were treated for infection, while none of the patients who received BerbereX® for their post-operative care required any further treatment. Of those 11 patients who were treated for infection, 4 had serious infections and 7 had incidental infections. For the 4 serious infections, 3 received wound vac treatment, and 1 patient was readmitted for care. Of the 7 infections noted within the lumbar fusion group, 2 were multi-level, and within the 4 infections treated in the decompression population, another 2 were also multilevel. The severity of those requiring more aggressive treatment was not found to be correlated with the number of levels or the incidence of infection.

Discussion: The rate of infection in the group of 144 patients receiving standard-of-care following surgery was nearly 7.6% while the incidence in those 66 patients treated with Berberex were zero. This data demonstrates that incisions will heal faster with better cosmetic outcomes then under current care protocols. In this quality practice initiative, data supports clinical observation that post-operative wound dehiscence, cellulitis, seromas, low-grade infections, associated incision infections and other pathologies of the incision sites related to healing are diminished. As an anti-microbial product, effective wound management is well paired with economic benefits in minimizing the complications of post-operative surgical incision site care. As such, it may serve as a candidate for post-operative care.