- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02767427
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
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New York, New York, United States, 10034
- Columbia University Irving Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: At-Home Chlorhexidine
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.
|
(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:
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EXPERIMENTAL: No At-Home Chlorhexidine
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.
|
Chlorhexidine wipes will not be used though it is a commonly used pre-operative skin cleansing measure.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Pre-Surgery and Post Surgery, up to 4 hours
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AAAP8304
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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