Clinical Trial: The Value of Home Chlorhexidine Pre-Surgical Wash Before Spine Surgery
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: The Value of Home Chlorhexidine Pre-Surgical Wash Before Spine Surgery
Brief Summary:
The study team hypothesizes that at-home cleansing of the surgical site with chlorhexidine wipes provide no added benefit to decreasing microbial activity or preventing surgical site infections.
Patients will be randomized to the chlorhexidine or no additional intervention groups. Patients will be randomized to use 4% chlorhexidine cloths, while the other half receive no additional intervention. Those randomized into the chlorhexidine gluconate home-application group will be asked to shower the night before surgery, and to use a standardized pre-packaged chlorhexidine gluconate wipe (that the patients would receive at their pre-surgical consultation) on their surgical site after thoroughly drying those areas. The patients will be asked to use a second wipe in each area the morning of surgery. The surgical sites will be analyzed in two groups: anterior cervical and posterior spine. Each of these two groups will be randomized separately. All patients will undergo a standardized preoperative cleansing regimen. Once positioned, they will be cleansed with an alcohol solution. Then, the surgical site (either the anterior portion of the neck or the posterior area of the spine) will be scrubbed with chlorhexidine soaked brushes and then painted with chlorhexidine solution. Perioperative antibiotics will be given per attending surgeon preference. Cutaneous samples will be taken from the surgical site of each patient at each time point.
Detailed Summary: To the investigator's knowledge no prior study has evaluated the effects of cleaning the skin at home before surgery in patients undergoing spine surgery. This study will investigate whether patients who use a chlorhexidine cleansing wipe have decreased amounts of bacteria on their skin when they arrive for scheduled spine surgery. Spine surgeons strive to decrease infections in their patients, so it is important to see if this intervention helps to do this.
Sponsor: Columbia University
Current Primary Outcome: Number of patients with no change in cutaneous bacterial load [ Time Frame: four hours ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Columbia University
Dates:
Date Received: April 23, 2016
Date Started: February 2016
Date Completion: December 31, 2017
Last Updated: February 7, 2017
Last Verified: February 2017
