Clinical trial NCT02767427: The Value of Home Chlorhexidine Pre-Surgical Wash Before Spine Surgery
Official title: The Value of Home Chlorhexidine Pre-Surgical Wash Before Spine Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infection
Spinal Injuries
Keywords: Infection Control
Preoperative Care
Chlorhexidine
Pre-Surgical Wash
Spine Surgery
Surgical site infections
Cutaneous bacterial load on skin
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Orthopaedic Scientific Research Foundation Inc
First posted: 2016-05-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 (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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Patients With Cutaneous Bacterial Load After Surgery
timeFrame: Pre-Surgery and Post Surgery, up to 4 hours
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Kiehyun D Riew, MD
role: PRINCIPAL_INVESTIGATOR
References: