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

Not Applicable

Completed

• Conditions: Infection; Spinal Injuries
• Interventions: Other: No intervention; Device: Chlorhexidine Wipes

• Registration Number: NCT02767427
• Lead Sponsor: Columbia University

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.

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-04-23
• Study First Submitted QC: 2016-05-09
• Study First Posted: 2016-05-10
• Primary Completion: 2018-05-31
• Study Completion: 2018-05-31
• Results First Submitted: 2019-05-17
• Results First Submitted QC: 2019-06-21
• Results First Posted: 2019-07-16
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-02
• Last Update Posted: 2023-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No At-Home Chlorhexidine	No intervention	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.
At-Home Chlorhexidine	Chlorhexidine Wipes	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.

Primary Outcome Measures

Name	Time	Method
Number of Patients With Cutaneous Bacterial Load After Surgery	Pre-Surgery and Post Surgery, up to 4 hours	All specimens were taken by a sterile BD E-Swab. All samples will be sent immediately after acquisition to the microbiology lab for analysis within four hours.

Trial Locations

Locations (1)

Columbia University Irving Medical Center; 🇺🇸 New York, New York, United States