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

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.

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Key information

Conditions

Infection Back Injuries Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Spinal Injuries Surgical Wound Infection Wound Infection Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Columbia University Irving Medical Center

New York, 10034, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chlorhexidine Wipes

Device

(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 names: 4% Chlorhexidine Wipes, Chlorhexidine Gluconate, Skin Prep Cloths, Sage Skin Prep Cloths

No intervention

Other

Chlorhexidine wipes will not be used though it is a commonly used pre-operative skin cleansing measure.

Primary outcomes

Number of Patients With Cutaneous Bacterial Load After Surgery

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

Orthopaedic Scientific Research Foundation Inc

Registry information

Important dates

Study start: 2016
Primary completion: 2018
Study completion: 2018
First posted: May 10, 2016
Registry last updated: Feb 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed