NCT02767427

The Value of Home Chlorhexidine Pre-Surgical Wash Before Spine Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Columbia University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 (CHG) home-application group will be asked to shower the night before surgery, and to use a standardized pre-packaged CHG 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 description

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.

Conditions

• Infection
• Spinal Injuries

Interventions

Type	Name	Description
DEVICE	Chlorhexidine Wipes	(Standard of Care) Chlorhexidine wipes are a commonly used pre-operative skin cleansing measure, designed to reduce bacterial load on the skin of the surgical site.
OTHER	No intervention	Chlorhexidine wipes will not be used though it is a commonly used pre-operative skin cleansing measure.

Timeline

• Start date: 2016-02-01
• Primary completion: 2018-05-31
• Completion: 2018-05-31
• First posted: 2016-05-10
• Last updated: 2023-02-06
• Results posted: 2019-07-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study