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

Primary Purpose

Infection, Spinal Injuries

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Chlorhexidine Wipes
No intervention
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Infection focused on measuring Infection Control, Preoperative Care, Chlorhexidine, Pre-Surgical Wash, Spine Surgery, Surgical site infections, Cutaneous bacterial load on skin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Columbia University Irving Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

At-Home Chlorhexidine

No At-Home Chlorhexidine

Arm 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.

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.

Outcomes

Primary Outcome Measures

Number of Patients With Cutaneous Bacterial Load After Surgery
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.

Secondary Outcome Measures

Full Information

First Posted
April 23, 2016
Last Updated
February 2, 2023
Sponsor
Columbia University
Collaborators
Orthopaedic Scientific Research Foundation Inc
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1. Study Identification

Unique Protocol Identification Number
NCT02767427
Brief Title
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
February 2016 (Actual)
Primary Completion Date
May 31, 2018 (Actual)
Study Completion Date
May 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
Collaborators
Orthopaedic Scientific Research Foundation Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection, Spinal Injuries
Keywords
Infection Control, Preoperative Care, Chlorhexidine, Pre-Surgical Wash, Spine Surgery, Surgical site infections, Cutaneous bacterial load on skin

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
At-Home Chlorhexidine
Arm Type
Active Comparator
Arm 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.
Arm Title
No At-Home Chlorhexidine
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
Chlorhexidine Wipes
Other Intervention Name(s)
4% Chlorhexidine Wipes, Chlorhexidine Gluconate, Skin Prep Cloths, Sage Skin Prep Cloths
Intervention Description
(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.
Intervention Type
Other
Intervention Name(s)
No intervention
Intervention Description
Chlorhexidine wipes will not be used though it is a commonly used pre-operative skin cleansing measure.
Primary Outcome Measure Information:
Title
Number of Patients With Cutaneous Bacterial Load After Surgery
Description
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.
Time Frame
Pre-Surgery and Post Surgery, up to 4 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kiehyun D Riew, MD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University Irving Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10034
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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