Surgical site infection (SSI) following spinal surgery is a frequent complication and
results in higher morbidity, mortality and healthcare costs. SSI following adult spinal
surgery is a frequent complication that has been reported to occur in 0.7-12.0% of patients
and result in higher postoperative morbidity, mortality and health care costs. Vanderbilt
University Medical Center SSI rate is 7%. Treatment for SSI can be challenging often
requiring revision surgery, long-term antibiotics, and prolonged hospitalization. The
accurate identification of risk factors is thus important in the development of strategies
to prevent these potentially devastating infections. This study proposes a randomized,
controlled trial of neuro-spine patients of 2% chlorhexidine gluconate skin preparation
cloths for the prevention of post op surgical site infections in spine patients.
Use of CHG cloths the night before and morning of surgery (neckline to toes) will affect
(decrease rates) of SSI compared to patients who receive routine standard of care (soap and
water pre-op, day of surgery and daily post-operative).
Pre-operatively patients scheduled for neurosurgical spine cases will be evaluated and
approached for interest, if consenting process completed, patients will be randomized to one
of 2 arms in 1:1 through a block randomization table.
Those enrolled into the study arm will receive the CHG cloths and instructions for use from
research personal. Those randomized to the control arm will receive standard of care skin
cleansing by nursing staff.
All subjects who have signed consent will have a skin swab culture taken the day of
screening and prior to cleansing with Chlorhexidine gluconate wipes close to the intended
incision line. The investigators will also obtain skin swab cultures at site of incision
preoperatively on the day of surgery, post-op day 4 or time of discharge and at the 30 day
Both groups will be evaluated daily by study personnel for the development of SSI until
post-op day 4 or hospital discharge whichever one comes first. After dressing removal, a
daily high definition picture will be taken of the incision line to further document signs
of SSI development (pictures will not have any patient identifiable information). Additional
evaluations will take place at the 30 day (+/- 7 days) post-op visit. Blinded evaluators
utilizing the CDC guideline will grade the incision line for presence of SSI. Measured
change in skin flora will be performed by comparing skin swab cultures of intervention group
versus standard of care group and individual changes pre and post operatively.
Patients scheduled for a neuro-spine procedure and have 2 of the following risk factors:
- Diabetic OR
- BMI>30 OR
- ASA>2 OR
- pre-operatively hospitalized OR
- >60 years old OR
- chronic steroids/immunosuppressive medications OR
- prior history of SSI
- Unable to consent
- Non English speaking
- Known allergy to any of the ingredients contained in SAGE chlorhexidine gluconate
- Current infection or history of spine infections
- Patients with tumors or intradural spinal pathology.
Nashville, Tennessee 37232
Elizabeth Card, MSN, APRN, FNP-BC
Site Status: Recruiting