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

Columbia University

Status: Completed

Conditions: Infection; Spinal Injuries

Treatments: Device: Chlorhexidine Wipes; Other: No intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT02767427

AAAP8304

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years old or older
• Scheduled for elective spine surgery at Columbia University Medical Center

Exclusion criteria

• Unable to apply at-home chlorhexidine wipe by themselves
• Deemed "high risk" preoperatively by the treating surgeon
• Diagnosed with spine trauma
• Undergoing deformity correction surgery
• Unable to consent to the terms of the surgery
• Known infection at time of the index procedure
• Hospitalized within 1 week pre-operatively
• Allergic to chlorhexidine
• Immunocompromised
• End stage renal disease on dialysis
• Local or systemic skin disease (such as psoriasis, eczema, etc.)
• Open skin wounds

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

At-Home Chlorhexidine

Active Comparator group

Description:

Those randomized into the chlorhexidine group will be asked to shower the night before surgery, and to use a standardized pre-packaged Chlorhexidine Wipes (chlorhexidine gluconate wipes) on their surgical site after thoroughly drying those areas. They will be asked to use a second wipe in each area the morning of surgery. Those who forget to use the wipe in the morning were allowed to use the wipe in the pre-operative area and included if this occurs more than one hour before skin prep.

Treatment:

Device: Chlorhexidine Wipes

No At-Home Chlorhexidine

Experimental group

Description:

Participants in this group will not use chlorhexidine wipes (no intervention), as is standard of care, prior to their surgical site being cleansed by the surgical team pre-operatively.

Treatment:

Other: No intervention